The Big Red Biotech Blog

Gentlemen, Start Your Lobbying for Biosimilars Regs

Today the FDA kicks off 2 days of hearings to begin public debate on regulations that will be needed to implement the follow-on biologics pathway that was autorized in the Price Competition and Innovation Act of 2009 - part of the healthcare reform. The FDA will have members from CBER, CDER and the Office of Compliance present at the hearings.

Other speakers will represent drugmakers, insurers, doctors, investors and policymakers of every shape and size.  The three major trade associations PhRMA, BIO and GPhA will also be presenting.  According to the announcment of this meeting in the Federal Register - the FDA will be seekign input on the following topics: biosimilarity, interchangeability, patient safety, pharmacovigilance, use of supporting data, definition of a biologic, need for guidance, exclusivity, transition provisions and user fees.

Amgen already issued a press release with its postions regarding on three key criteria: 1. Need for well controlled clinical trials to establish biosimilarity, 2. Identification of manufacturer and lot number for all administered bio drugs, and 3. Set scientific criteria for interchangeability.  Presumably, Amgen will argue that these should be as rigorous as possible as it has a portfolio of biologic drugs, and will face challenges to its drugs like EPO as early as 2014.

For more resources on this topic - see Fierce Biotech, Pharmalot, and PharmaTech Talk.  The Pharmalot link actually will allow you to access another link to a webcast of the hearings.

 

Posted by Bruce Lehr November 2nd 2010.

NICE loses Cost-effectiveness Super Powers!

The UK's NICE is soon to lose its "superpowers" when it comes to rejecting new medicines for use on the National Health Service (NHS) plan.  NICE will be reduced to an advisory role only - doctors will make the final treatment (i.e drug access) decisions.

The UK will now move to so-called value-based pricing.  Under this new system, drug company prices will be largely based on scientific evidence of value in clinical practice. Theoretically, decisions will be less pure cost based (current limit is about $34,000 in UK) and will take into account value delivered for the cost spent. See Pharmalot.

NICE's former powers to exclude drugs have been blamed by consumer groups for dismal cancer survival rates in UK and a lot of untimely deaths.  New cancer drugs were frequently rejected by NICE due to their high costs -- even if clinically effective according to its critics.  NICE defended this practice by saying that left more to spend on other conditions.  

Now the government will attempt to drive pharma companies to prove their drugs are cost effective and clinically effective -- and will deliver value.  The idea is to get drug companies to bring forth their drugs capable of proving their worth. Otherwise, more marginal drugs, that are expensive too, will be restricted to limited groups of patients where no better option exists. NICE will likely die after a suitable transition period.

 

 

 

Posted by Bruce Lehr November 2nd 2010.

CEOs Surveyed on Promise of Therapeutic Discovery Tax Credit

Previously, I've published an update from GEN on the progress being made with applications for the Qualifying Therapeutic Discovery Project tax credit that was a $1 B fund set up as part of the Patient Protection and Affordable Care Act (healthcare reform) passed in March.

As a further update, MNT published a BIO survey of 125 CEOs from small to medium biotechs (this tax credit is avaialble to companies with <250 employees) as to their perceptions of the Project's value. The consensus opinion is that the program is a big benefit to the US Biotech industry and should be continued. 

Jim Greenwood, president and CEO of BIO said  "America is the world leader in biotech, and we hope Congress will consider extending and expanding this program to support American innovation and speed the development of life-saving cures."

Here are some key reponses from the survey:

• 75% CEOs say tax credit will have positive effect on job sustainability in the US
• 72% say it will help US biotech's global competitiveness
• 76% say it will advance life saving cures and therapies
• 67% say it will help them create more jobs and hire more staff
• 30% say they can maintain current employment levels which would not happen otherwise

I've stated before that I think that it is good public policy for the US Government to provide tax incentives for investment and support in the  biotech industry to help it maintain a World leadership position.  Recipients for this last round of tax credits will be announced sometime next week and I'll follow up on that here.

 

 

Posted by Bruce Lehr October 30th 2010.

 

 

We Need a Refocused, Kinder, Gentler NICE

The UK's NICE is often the butt of criticism with regard to its measures of drug cost effectiveness and its ability to recommend a thumbs up or down for use of a given therapy. Recently, the Association of the British Pharmaceutical Industry (ABPI) has called for a change in NICE's remit as reported in MNT.

The Director General, Dr. Richard Barker of the APBI suggested a three point plan for NICE's future:

• Broaden NICE's definition of value to capture all elements of healthcare innovation
• Refocus attention on best practice and quality standards and how innovation can enhance both
• Stop National Health Service practices that 'second-guess' NICE

"If we want the NHS and the UK economy to benefit from a vigorous life sciences sector, the reshaping of NICE's remit is an urgent priority. A focus on the future value of innovation, rather than decisions made on narrow cost-effectiveness criteria, would mean that NICE could play an important pivotal role in an outcomes-driven NHS."

Broadly, I agree with ABPI's position. I think cost-effectiveness measures of healthcare, representative of NICE's current charter are here to stay.  We really need to look at outcomes along with costs to keep medicine affordable.  However, a cost effectiveness  system that stifles or prevents the prospect of innovation is highly undesirable.  So if an organization like NICE, can have its marching orders tweaked so that it can both look at cost effectiveness but in the context of best practice and quality standards and improve access for patients that will be the best outcome.

As Frank Burns might say, "It's nice to be nice to the NICE".

 

 

 

 

Posted by Bruce Lehr October 21st 2010.

 

 

FDA to Hold Biosimilar Rules Hearing - BIO Gives Its Positions

Previously, the FDA had announced that it will be holding public hearings on November 2nd and 3rd to get feedback toward forming regulations for the approval of biologics.  Today, I received a newsletter from the industry group BIO detailing their key positions on the matter.

 

Let's give you the highlights:

Patient safety

• Approval of biosimilars should be based on the same rigorous standards for the approval of pioneer biotechnology products
• Clinical trial data are fundamental to evaluating and demonstrating safety and efficacy of biosimilars for patients
• Biosimilars must be properly evaluated through post-marketing surveillance
• Biosimilars should receive a nonproprietary name readily distinguishable from the pioneer product

Recognize scientific differences between drugs and biologics

• Versions of a biologic made by different manufacturers must be evaluated on a case-by-case basis
• Small product or manufacturing differences in biologics can result in significant differences in safety and effectiveness

Maintain physician-patient relationship

• The existing science is not sufficient enough to establish interchangeability
• Patients should not be given biosimilars unless prescribed by their physician

Preserve incentives for innovation

• Include substantial nonpatent exclusivity where follow on manufacturers can't cite pioneers' data
• Biologic products should not be approved until all statutory protections are no longer in effect for the pioneer product
• Any biosimilars regulatory pathway should not create special patent litigation rules that favor biosimilars manufacturers

Transparent statutory and regulatory processes

• Manufacturers of innovative products should be provided the opportunity to engage Congress and other key stakeholders in a public process in the establishment of a biologics regulatory pathway
• The FDA should follow a transparent and public process in determining data requirements for follow-on approvals


Continue to prioritize FDA review and approval of new therapies

• Make sure that new biosimilar applications do not harm the FDA's ability to efficiently review new drugs and biologics
• New treatments should continue to have highest review priority


In summary

• Make it hard for biosimilars to be approved
• Don't allow easy substitution once approved
• Provide more incentives/protections to pioneer drug makers
• Review our applications before the agency first
• Show us publicly that you are following these steps

That about does it.  As lobbyists they appear to be earning their keep.

Posted by Bruce Lehr October 12th 2010.

 

 

 

 

 

 

 

 

Medicare, Comparative Effectiveness and Reimbursement

Comparative effectiveness won't just retreat into the background.

The WSJ Health blog reports that two more researchers, Steven Pearson - president of the Insitute for Clinical and Economic Review and Peter Bach - an associate attending physician at Memorial Sloan-Kettering Cancer Center, are the latest to suggest Medicare should pay more for therapies that actually work. Hmmm. Novel thought. They term this a "dynamic pricing" model.  Sounds like comparative effectiveness to me.

Under their plan, a new therapy would be priced under existing formulas. After three years, with data in hand as to the benefit or lack thereof, the therapy could be repriced. Under current policy, Medicare covers therapies that meet a "reasonable and necessary" standard plus a profit margin. These authors suggest once a "reasonable and necessary" finding is reached that Medicare should also look at comparative effectiveness in setting the reimbursement rate.

They argue that for new treatments - companies and clinicians will now have greater incentive to generate appropriate data supporting the fac that their treatment actually works better than an existing one - in order to justify a reimbursement premium.  

 “A shift in Medicare’s fundamental approach to coverage and reimbursement decisions would require new legislative authorities and would be highly contested by those with a vested interest in existing reimbursement systems,” the authors write. The difficulty of changing legislative, regulatory and political processes “is hard to overstate,” they write.

Clearly, no change of this magnitude will come easy. However, economic reality is that more and more treatments need to pass an effectiveness test. There should be a requirement to show a medical or patient benefit in order to justify a pricing premium and to expect government or third party reimbursement.  Pricing can't be based solely on what it takes to earn a return on investment for the manufacturer - that's fine if there is also a measurable benefit - and its well past time that we start measuring.

 

 

Posted by Bruce Lehr October 6th 2010.

 

Big Pharma Absorbs $5 billion in fines! "The cost of doing business!"

Here's one from the excellent PharmaGossip blog that I must admit that I find to be sad and disturbing. This is a report of a study performed by The British Medical Journal and the Bureau of Investigative Journalism, City University, London

PharmaGossip: $5 billion in fines! "The cost of doing business!".

Effectively, we seem to have fostered a system whereby big pharma engages in fraud - usually off label marketing - as a standard business practice in order to hit market return expectations.  This would also include kickbacks and "entertainment" for physicians (KOLs) - a sum said to exceed $200 M in recent years.

In the last 2 years alone, 6 of the top 10 pharmaceutical companies have been fined for fraud in the US with a further 3 undergoing investigations. The total paid out has been $5 B in fines. (Of the top 10, only Roche remains untouched by US government).

Pharmaceutical fraud is one of the US’s top 3 “threats” says Sharon Ormsby from the FBI Financial Crimes Unit, because everyone is touched by these frauds (of the billions going into US healthcare, 3 - 10% is believed to be siphoned off into fraud — a large amount that could go to needy patients. Healthcare Reform anybody?

I would encourage you to follow the link and read the rest of the article for more in depth examples and discussion.  But it appears that we've institutionalized this behavior to an alarming degree and that it is in fact more cost effective for companies to just pay the fines and continue business as usual - as the proftis reaped far outweigh the financial penalties.

At the risk of moralizing further, I will refer readers back to a few other blog posts (see here and here) on related topics.  I do think we need to refresher course in focusing on patient welfare and getting back to the roots on which the industry was founded - which I firmly believe was NOT more profits at any cost.

Let's try to remember  that maximizing the "good" a  company does is related to greater profitability, equity and return on assets, and creates more shareholder value.  And it is the right thing to do!

 

 

 

Posted by Bruce Lehr October 2nd 2010.

 

 

Medicare To Grill Dendreon's Provenge?

The Centers for Medicare and Medicaid Services is about to conduct its previously announced National Coverage Analysis for Dendreon's newly approved (June 2010) Provenge.

Here's What Medicare Will Ask About Provenge // Pharmalot.

NCA reviews are considered unusual for newly licensed products.  And to make it more so, CMS apparently plans to ask questions about the drug's efficacy for on label uses! Part of its charter?  See prior blog post on Senate queries into why Medicare was conducting an NCA review in the first place.

Writes ISI Group biotech analyst Marc Schoenebaum. “This is the first time we’ve seen Medicare analyze the efficacy of a drug.”  There apparently is a first for everything.

Posted by Bruce Lehr September 27th 2010.

House Closes Healthcare Fraud Loopholes!

The House passed a bill today that will prohibit execs caught in healthcare fraud from doing any future business with Medicare and Medicaid.  It will also allow the government to exclude parent companies that may be committing fraud through subsidiaries (or shells) from doing business.

House Passes Bill To Ban Execs For Healthcare Fraud // Pharmalot.

This is seen to be a much tougher penalty on companies convicted of fraud than a mere fine. Fines often represent a very very very minor fraction of revenues that can be earned via fraudulent activity - and don't seem to be much of a deterent.

The Senate will still need to act for the bill to become law. Round 'em up.

 

 

 

Posted by Bruce Lehr September 23rd 2010.

 

 

 

Cost-Effectiveness and Health Care Policy

The world is changing and with it health care policy. The role of cost effectiveness analysis is being hotly debated in public policy quarters.  Many economists, health care policy experts, third party payers, governments, etc. have written on the issue and have openly questioned our society's) ability  to continue to pay for expensive me-too drugs or drugs, particularly in the oncology area, that are very expensive and providing what could be viewed as minimal survival impact.

There is an increasing view that future drugs will have a much higher burden in showing that they offer value over competitive drugs on the market -- in many cases this will boil down to showing that they are more cost-effective to use and/or offer true patient benefit.  As the concept of measuring a drug's cost-effectiveness or comparative effectiveness has evolved - so too has the term "quality-adjusted life year" or QALY emerged as a tool to standardize the measure of benefit provided by a particular therapy.

The QALY measure is controversial in and of itself.  QALY (as explained by Peter Neumann, Director of Tufts Center for Evaluation of Value and Risk in Health in HealthBlawg) is an attempt to combine morbidity and mortality into a single number and to assign a cost for achieving that number. To illustrate, a particular cancer drug may extend a patient's life by 1 year, but the patient lives that year in poor health.  We might estimate that the impaired extra year really represents only a 1/2 a year or 1/3 year - quality-adjusted life year gained. The idea is then to compare QALY for different drugs as a tool to help understand which may be more cost effective.  A drug that costs $10,000 per QALY is more cost efficient that a drug that costs say $200,000 per QALY.  Some health care system's are now saying they won't pay for the expensive, the $200,000 example, but would pay for $10,000.

The UK's National Institute of Health and Clinical Excellence (NICE) may be a particularly villified (in some quarters) institute that has used QALY as a means for helping it to decide which treatments it would recommend for funding and which would be rejected. NICE certainly has rejected paying for some expensive new approved drugs such as Avastin for bowel and kidney cancer, Tarceva for lung cancer, Menatime for Alzheimer's (Germany's IQWiG also turned down), Nexavar and Torisel for kidney cancer,  Sutent (as second line treatment), and Velcade for multiple myeloma.  Sutent was later approved as a first line treatment after Pfizer agreed to drop its price.  The National Health Service (NHS), in a novel deal, agreed to pay for Velcade for patients that responded to therapy while those that did not would be removed and the manufacturer would refund treatment costs.  See here and here for recent articles covering the Rare Cancers Forum report on NICE performance with cancer drug approvals. NICE consistently resists approving a drug with a QALY in excess of $50,000.

This concept of cost-effectiveness based rationing is somewhat further along (and more accepted) in Europe.  It is more anathema to a US audience.  Americans are used to getting what they want and perhaps feel entitled to access to these new treatments, if available, regardless of cost. There is apparently a term for this in health care policy fields, American Exceptionalism. News Blaze reported on a new poll from an organization known as 60 Plus, 63% of Americans oppose a pending FDA decision that bases cancer treatment options on cost, 71% are more apt to vote against candidates who support such FDA decisions - this stems from the FDA's recent decision to "de-label" Avastin for the treatment of breast cancer - which could remove it from Medicare, Medicaid and private insurance coverage for this indication.  Americans remain united in their opposition to prospect of health care rationing that "puts a price on a human life."  The Senate recently got involved as well when Medicare decided to evaluate Dendreon's Provenge post-approval.  Presumably Medicare is taking a look at its cost with an eye toward limiting its reimbursement.  Up till now Medicare has not done this with a recently approved drug and is not supposed to take cost into account when reviewing.

 But can we afford to do otherwise going forward?  Rationing will face tough opposition. More results form the 60 Plus poll:

• 56% of registered voters believe rationing is coming after Healthcare's passage
• 82% believe that cost-effectiveness is NOT a justifiable criterion for rationing
• 71% believe "the government is likely to limit treatment options through Medicare and Medicaid based on cost..."
• 85% say they will be truly "angry" if in fact Medicare and Medicaid coverage is rationed
• 72% believe the FDA shoudl have nothing to do with cost-effectiveness decisions

Doesn't sound like too many will be helping NICE relocate to the US anytme soon -- at least not voluntarily. 

Contrast the above sentiments with an Forbes article by Robert Langreth where he interviewed Memorial Sloan Kettering oncologist Leonard Saltz.  Saltz says that as cancer drug prices continue to soar that doctors, patients and society will need to decide what they are willing to pay for -- otherwise we crash and burn as a healthcare system.  Saltz says our current practice of paying for very expensive treatments with minimal benefits is "encouraging mediocrity".  We've trained our pharma companies to aim low and deliver to the minimum standard with too many "me-too" drugs (more on that topic in the next post).  Saltz says nobody has been willing to draw the line on what a month of life is worth -- and as a result cancer treatment costs have soared well out of proportion with their meager benefits.  Saltz says we need a kinder, gentler version of NICE - one with doctor and patient representatives and less top down bureacracy - to keep drug costs from soaring out of control.

Finally, from Peter Neumann, "I think there will continue to be a lot of concern and sensitivity around doing cost-effectiveness analysis openly.  I think it's still fraught with a lot of political problems and mistrust and so forth.  However, I think that we will slowly but steadily begin to use more of this information and we are beginning to see it -- even in Medicare we are beginning to see it on the prevention side."

 Posted by Bruce Lehr September 16th 2010.  

Appeals Court Rules Pay for Delay Today is OK!

Looks like the Congress may indeed need to pass the Preserve Access to Affordable Generic Drugs Act if it wants "pay for delay" tactics to stop.  The Federal Appeals court today declined to change its April ruling that pay for delay settlements were legal.

A group of direct and indirect drug purchasers, CVS Caremark and Rite Aid, had filed the suit in relation to a Bayer paying Barr Pharmaceuticals to drop a patent challenge against Bayer's drug Cipro.  The next step for the plaintiffs would be to take their appeal to the Supreme Court - which too may or may not choose to hear the case.

The ruling is in opposition to the intent of the Senate Committee voting for its bill. The US FTC has voiced its opposition to pay for delay settlements, and recently has been joined by the Department of Justice which has said these agreements should be presumed unlawful. See WSJ article.

In the meantime, pay for delay will stay.

Posted by Bruce Lehr September 7th 2010.

 

The Feds Need to Start Supporting Early-Stage Drug Development

Here is a good post from Xconomy by Shawn Iadonato, CEO of Kineta in Seattle.  In it, he argues that in order for the NIH to better support its stated mission "to improve human health and reduce the burdens of illness and disability" by "acclerating cures", it must do more to support translational research with funding for biotechs.

The Feds Need to Start Supporting Early-Stage Drug Development.

He makes the point that while Big Pharma annual R&D spending has increased 6 fold between 1982 and today - the number of drugs making it through the pipeline is virtually unchanged (if not down slightly). If you look at NIH funding, most of that is focused toward Universities and basic research. He cites this example.  In 2009, an incremental $10 B in NIH funding was approved in the Amercian Recovery and Reinvestment Act.  Of the 406 ARRA grants going to Washington State, only 5 went to provided to biotechs. He argues that excluding biotechs doesn't help new drug development or job growth in Washington, and small businesses are effectively cut out of the stimulus package by this type of allocation.

He concludes that academic institutions are clearly important to basic research.  However, they are not designed to develop drugs.  Since Big Pharma has largely removed early translational research from its R&D groups (in favor of outsourcing), that leaves small biotechs as the last line of defense in doing this important translational work. Therefore, if NIH wants to truly accelerate cures, it should change its allocation procedures and send more money in support of this research at biotechs.  This is the best way to speed development of high-need new drugs.

I think you couple policy changes in this direction, with the $1 B in tax and grant provisions for small and medium biotechs in the latest healthcare reform bill, and you will begin to make an impact in drug development in the biotech environment.  This is especially true given the more difficult venture capital environment in this sector - although that appears to be improving somewhat.  The industry is restructuring.  Big Pharma is changing its development model to become more dependent on CROs, CMOs, biotechs, etc.  It is time for the funding mechanisms used by the Federal Goverment to modify and change as well.

Posted by Bruce Lehr September 3rd 2010.

GEN Provides Update on Tax Credits for Small and Medium Drug Firms

Here is a nice update from GEN on the tax credit portion of the Patient Protection and Affordable Care Act (i.e. Healthcare reform bill) passed in March.  As expected, participation was brisk with up to $1 B in grants or tax credits up for grabs. 

According to GEN, the average applicant applied for help with 2 or 3 projects.  There was an average claim for each Qualifying Therapeutic Discovery Project (QTPD) of approximately $9 M per application. Maximum awards have been established at $5 M though.  Of companies applying, the average number of employees was only 20 - thus the program truly is appealing to small life science groups. 

Awards will not be announced until late October.  At that time, we will know the total number of applicants and applications approved.  Based on response so far, general observers believe the program should be renewed. It's felt that this type of funding for small companies can make the difference between successfully completing a project or pulling the plug.

Posted by Bruce Lehr September 2nd 2010.

DIPP Discussion Document into Compulsory Licensing and Price Controls

As posted late last week, India's Department of Industry Policy and Promotion (DIPP) proposed changing compulsory licensing to ensure drug availability and affordability in the country.  This action is arising out of fears by some that the India Pharma Industry is becoming rapidly consolidated amongs larger firms and in particular multi-nationals.  The result has been a rapid rise in exported drugs -- from 18% of revenues in 94-95 to more than 52% in 08-09.  Foreign owners now account for 3 of the top 10 Indian drug companies.

DIPP published its discussion document last week for comment. See here Download DIPP CL-DraftDiscussion[1].

Posted by Bruce Lehr August 30th 2010.

New Medicines Plummet to All-time Low since the Second World War

This comes to us from the Independent via the PharmaGossip blog.  It is another article documenting the patent cliff -- $142 B worth of drugs falling down over the next 5 years.  This time, not only detailing what's coming off patent, but reiterating the lack of new drugs that are making it through the approval process.

PharmaGossip: "The number of new medicines is at an all-time low and is as low as it has been since the Second World War," - The Independent.

Pharma companies will be losing 14 to 41 per cent of their existing revenues in that 5 year span. There is debate as to whether pharma should continue to invest so heavily in R&D for new "blockbusters". A new PricewaterhouseCoopers (PWC) report, Pharma 2020: The Vision, notes that in the six years from 2001 to 2007, the FTSE pharmaceutical index grew only by 1.3% versus Dow Jones World index rise of 34.9%.  Only 5 of the top Big Pharma generate more than 10% of their revenue from drugs introduced since 2001.  Yikes! The industry is spending 2x as much on R&D and only getting 2/5 as many products to market as a decade ago.

The PWC report isn't all gloom (a few rays of sunshine).  PWC does point out that the global pharma market is still expected to grow from its current $518 B size to as much as $1.3 trillion by 2020. Growth in pharmerging countries is expected in strong double digits. World population is still expected to grow to 7.6 billion by 2020 and there will be an increase in people over the age of 65 from $477 M to more than $719 M during that time.  This population are big users of prescription drugs -- 75% of whom take at least 1 prescription, and 33% take more than 4 prescriptions (especially in my family).

Check out another closely related topic, regarding "Why in-licensing is not the cure", from Seeking Alpha. This speaks heavily to a Morgan Stanley and Accenture reports that urge big pharma companies to follow an "Integrated Therapeutics" model.  A model not dependent solely on producing innovative medicines.  Rather, the companies focus on producing a "suite of medical solutions that include risk-sharing pricing contracts, drug delivery devices, companion diagnostics, or care management services."  This way meaningful value is added to the product, beyond solely the molecule, and benefits are generated for the many parties involved including patients, payers and drug makers.

Posted by Bruce Lehr August 30th 2010.

 

 

Senators Ask Why Provenge Being Reviewed for On-Label Use?

As detailed in Ed Silverman's Pharmalot blog, two US Senators are asking questions with regard to Medicare's review of Provenge.   They note that it is not standard by any means to review a drug for an approved use.  Off-label? Yes.  Approved on-label? No.

Senators Ask Why Medicare Is Reviewing Provenge // Pharmalot.

The Senators suspect that Medicare may wish to restrict coverage - presumably due to its high cost.  Such a review is NOT common for new drugs and price is NOT supposed to be part of the analysis. Stay tuned.

Posted by Bruce Lehr August 26th 2010.

PhRMA Fires Back at AARP Report

Here is PhRMA's analysis and response to the AARP report issued yesterday on drug price increases.  Not surprisingly, PhRMA is critical of the AARP analysis and responds that drug prices have grown slowly in the past the year.

Full statement.

Posted by Bruce Lehr August 26th 2010.

Drug Prices Rose 8 Percent Last Year

From Pharmalot blog this morning, the AARP reported that on average drug prices increased by 8.3% in 2009 - despite world wide recession and a drop in inflation.

Drug Prices Rose 8 Percent Last Year: AARP // Pharmalot.

For the most popular drugs, that increase was a whopping, eye-popping 41.5% as compared to a 13.3% increase in the Consumer Price Index.  Consultants criticized the study as focusing only on branded medications and noted that generics are widely available in the US and very competitively priced with rapidly growing market share.

By contrast a US Bureau of Labor Statistics study found an overall price increase for drugs at much more modest 3.4%.  We may have another case of lies, damn lies and statistics. 

Posted by Bruce Lehr August 25th 2010.

 

India DIPPs into Compulsory Licensing and Price Controls

As reported in in-Pharma Technologist.com, the Indian Department of Industrial Policy and Promotion (DIPP) is considering greater compulsory licensing provisions for drug makers.  These provisions could be applied, if necessary, to 3rd party drug (MNC) companies that takeover local generic competitors.  Indian regulators fear the upsurge in this type of activity in the recent past could result in pricing local populations out of the market in key therapeutic areas -- like cancer treatments where pricing often makes drugs too expensive for patients to access.

DIPP is careful to emphasize that compulsory measures would be used "when a single critical drug is either unavailable per se or unavailable at reasonably affordable prices".  DIPP is inviting public comment on when compulsory measure should be invoked and how compensatory royalties should be handled.

Posted by Bruce Lehr August 25th 2010.

“Nowhere to hide” -- Europe's Price Controls Hit Drugmakers

According to IHS in the Pharma Letter, European government price controls have hit drugmakers pocket books. Further, the effect is seen with both brand name and generic producers.  This "recession proof" industry is -- well --

“Nowhere to hide,” says IHS, as Europe's austerity measures impact drug firms - Pharma Letter.

Unrecession Proof.

Posted by Bruce Lehr August 12th 2010.

India Wants to Stop Drugmakers “bribing” Physicians

This from the Pharma letter.  India is the latest country to explore drug price controls to improve patient accessibility and a hard cap on drug profit margin, while promoting the use of generics.

Indian Parliamentary health committee calls for cap on profit margins from medicines and a stop to drugmakers “bribing” physicians - Pharma Letter.

In addition, there is also a provision in the proposal to pull a drug manufacturer's license if they are caught bribing physicians.  Imagine! What's the world coming to?

Posted by Bruce Lehr August 11th 2010.

Pay for Delay Dismay in Play

As recounted in the PharmaTech Talk blog a Senate panel approved legislation to prohibit ethical drug companies paying generic competitors to delay bringing their products to market.  Both US and EU authorities have considered these so called "pay to delay" agreements anticompetitive. 

PharmTech Talk » Protection from Patent Dependence.

The FTC noted that there were 21 of these deals in the US in the first 9 months of 2010 - more than in all of 2009.  Consumer advocates estimate these deals could cost consumers billions of dollars in additional drug expenditures. Healthcare Reform being very cost conscious - needless to say these type of deals have been under scrutiny for some time and are high on the FTC hit list to bring to an end.

Under the new proposed legislation, Preserve Access to Affordable Generics Drugs Act, such settlements would be deemed illegal.  The burden would be on the companies entering such agreements to show that they were not anticompetitive.

Posted by Bruce Lehr August 4th 2010.

UK to create £50 million cancer drugs fund

Andrew Lansley, the UK's Health Secretary, announced that a new 50 million pound fund would be created beginning in October to improve access of NHS patients to new cancer drugs.

Lansley to create £50 million cancer drugs fund | InPharm.

The announcement was made following the issuance of a new report that shows the UK lags behind other European nations in the uptake of new cancer medications.

Posted by Bruce Lehr July 28th 2010.

Biosimilars are Here to Stay - Deal with It!

The WSJ Health blog published on a report yesterday recently released by the Generic Pharma Association (GPhA) touting the savings the US healthcare system is deriving from using generic drugs in the stead of their branded counterpart.

According to the report, every 2% uptake in generic utlization results in $1 B in Medicaid annual savings.  A billion here and a billion there and pretty soon you'e talking about real money. What's more? Utilization of generics within the Medicaid program is about 10% below that of the general population -- meaning there is much more savings to be had.  In total, the GPhA claims that IMS figures support a realized savings of more than $139.6 B due to generics usage in 2009 -- a 15% increase from prior year.

What does this mean?  It means that economica favor the substitution of generics whereever possible - certainly from the 3rd part payer persepective.  Even though the savings are not be projected as high with biosimilars compared to their branded counterparts, there are still ample savings to be realized. One can hardly expect Medicaid adminsitrators to ignore this.

This week the FDA approved a generic biologic from Momenta Pharmaceuticals that will compete with Sanofi's Lovenox branded drug. The drums are already beating that this signals a more assertive stance by the agency toward approving additional biologics and biosimilars.  Teva's Copaxone has been identified by several analysts as perhaps the next branded biologic to be challenged.

Novartis' Jeffrey George, global head of Sandoz generic drug unit, says that starting in 2015 and 2016 many biotech product will begin to come off patent. "Biologic medicine is a $100 B industry.  There is a lot of savings to be had."  Epogen and Neupogen might be the first targets on this list.

Bottom line: the FDA has let the genie out of the bottle with its approval of Momenta's generic and there's no going back.

Posted by Bruce Lehr July 27th 2010.  

FDA Gives Green Light For Momenta's Generic Biologic Anti-Clotting Drug

Katy bar the door - the FDA has just approved the first biologic generic anti-clotting factor from Momenta Pharmaceuticals (and Novartis).  This is expected to be a spirited competitor to Sanofi-Aventis SA's Lovenox - a $4.57 B drug. 

Momenta Gets FDA Green Light For Generic Anti-Clotting Drug; Shares Boom.

Momenta's shares soared 70% on the news and Sanofi-A'ventis' stock took a 5% hit.  This approval might be seen as a harbinger that the FDA is going to be willing to assertively approve new biologics.  While Momenta's drug is not genetically engineered, it is a complex biologic and this approval may signal how the FDA may view recombinant biologics when judging equuivalency.

Teva's Copaxone may be next on the list to be challenged by a biologic generic.

Posted by Bruce Lehr July 23rd 2010.