- The government agency in charge of approving drugs gets a surprising amount of money from the companies that make them (businessinsider.com)
Getting a drug all the way to approval is no easy feat — for pharmaceutical companies or for regulators...in 1992, the Prescription Drug User Fee Act was passed, making it the law for pharmaceutical companies to directly pay the FDA to review their applications for drug approvals. That way the FDA has more resources to conduct rigorous and timely reviews, pharma companies get products through the regulatory pipeline faster, and patients get new drugs more quickly. Win-win-win, right?...That's one way to look at it. But others have argued that PDUFA...puts the FDA in the pockets of the drug industry...In the same way that doctors are accused of subjecting themselves to bias when they receive consulting or speaker fees from a drug company, so has the FDA been accused of kowtowing to the pharmaceutical industry... since PDUFA was passed in 1992, pharma companies have contributed $7.67 billion to the federal agency…User fees are increasingly central to the funding of the drug, biologic and device review programs, and in some cases these fees account for a larger proportion of the FDA budget than congressionally appropriated monies...
- California senator withdraws ‘gutted’ drug price transparency bill (statnews.com)
A closely watched effort in California to pass a bill that would require drug makers to explain their price hikes has been scuttled. The decision came after amendments were made during an assembly committee hearing last Friday that sources told us "effectively gutted" the legislation...The bill would have required drug makers to report any move to increase the list price of a medicine by more than 10 percent during any 12-month period. And drug makers would also have had to justify price hikes for medicines with a list price of more than $10,000 within 30 days of making such a move..."Unfortunately, recent amendments have made it more difficult for us to accomplish our fundamental goal," said California state Senator Ed Hernandez, who pulled the bill after introducing the legislation and succeeding in getting the state Senate to approve the measure two months ago...Although Hernandez said he hopes to reintroduce the legislation at some point, the withdrawal is a significant victory for the pharmaceutical industry...
- ACLU threatens to sue Colorado over hepatitis C drug restrictions (statnews.com)
In the latest dust-up over the high cost of hepatitis C drugs, the American Civil Liberties Union is threatening to sue Colorado officials if they refuse to widen access to the medications in the state Medicaid program...The saber rattling came in response to a long-standing policy by the state Medicaid program to restrict coverage only to people with the most advanced stages of liver disease, such as cirrhosis...“Basically, Colorado has been withholding treatment from Medicaid recipients until they have measurable damage to their livers. And we believe that the restrictions violate the Medicaid statute,” Mark Silverstein, the ACLU of Colorado Legal Director...“We hope they’ll do the right thing, but we’re prepared to pursue litigation otherwise.”...Since 2013, the state has spent $26.6 million treating 326 hepatitis C patients, or about $82,000 per person, according to a spokesman for the state Department of Health Care Policy and Financing, which oversees the state Medicaid program. If the state were to cover every Medicaid patient with hepatitis C, regardless of the stage of their disease, it would cost $174 million. “It could be a budget problem,” he said.
- Investors making huge returns in Vietnam drug stocks (theglobeandmail.com)
As Vietnam opens up to more foreign money, the country’s fast-growing pharmaceutical industry is emerging as one of the most attractive prizes for overseas investors...Domesco Medical Import-Export JSC, the third-biggest listed drug maker, has shot up about 150 per cent this year as it got shareholder approval to scrap the 49-per-cent foreign ownership limit on its stock. DHG Pharmaceutical JSC, the largest, has risen about 44 per cent, with Japan’s Taisho Pharmaceuticals Holdings Co. buying a 24.5-per-cent stake last month. Vietnamese health-care companies have returned 46 per cent in 2016, the best performance among 10 industry groups on the VN Index...Vietnam’s pharmaceutical market is forecast to increase to $7.2-billion (U.S.) by 2020 from $4.2-billion in 2015 and then maintain double-digit annual growth through 2025...The industry will keep growing at about 10 per cent to 15 per cent a year...
- Patents vs. Market Exclusivity: Why Does it Take so Long to Bring Generics to Market? (raps.org)
It’s well known that generic drugs are just as safe and effective as their brand name counterparts. They’re the cheap knockoffs that help more people around the world gain access to innovative and sometimes life-saving treatments; the boring copycats made by companies you’ve never heard of and sold in plain bottles with little fanfare...what’s constraining the dissemination of these small molecule generics...isn’t the Food and Drug Administration and the backlog of abbreviated new drug applications, but a patent and market exclusivity system that can reward pharmaceutical companies long after they’ve recouped their research and development expenses and, at times, hefty profits…Patents and exclusivity work in a similar fashion but are distinctly different from one another. Patents are granted by the patent and trademark office...and can encompass a wide range of claims. Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA [new drug application] applicant...Exclusivity was designed to promote a balance between new drug innovation and generic drug competition...
- Are PCSK9 meds worth the cost? Only if Amgen, Sanofi and Regeneron slash prices by two-thirds: JAMA (fiercepharma.com)
Payers who’ve balked at a new class of cholesterol meds now have more justification. A new study concluded that Amgen, Sanofi and Regeneron would have to slash their prices by more than two-thirds to make them worth the cost...Repatha (evolocumab) and...Praluent (alirocumab) are both sticker-priced higher than $14,000 per year...study comes from the Journal of the American Medical Association...authored by academic researchers...And its conclusions are strikingly similar to previous assessments...Researchers found that using the new PCSK9 meds, rather than...ezetimibe...would save $29 billion on care for cardiovascular complications over 5 years. But the cost of those drugs would run an estimated $120 billion...Reducing annual drug costs to $4,536 per patient or less would be needed for PCSK9 inhibitors to be cost-effective…The drugmakers have taken issue with those analyses, mostly for their assumptions that all eligible patients would be put on the drugs--an overly rosy projection for drug sales. Payers’ prior authorization hurdles are already restricting uptake; up to three-fourths of patients are being turned away...So far, both drugs have underperformed expectations...
- Aetna CEO Threatened Obamacare Pullout If Feds Opposed Humana Merger (huffingtonpost.com)
...Aetna...announced...it was dramatically scaling back participation in the Affordable Care Act ― thereby reducing insurer competition and forcing customers scattered across 11 states to find different sources of coverage next year...Aetna officials said the pullout was necessary because of Obamacare’s problems ― specifically, deep losses the insurer was incurring in the law’s health insurance exchanges...But the move also was directly related to a Department of Justice decision to block the insurer’s potentially lucrative merger with Humana, according to a letter from Aetna’s CEO obtained by The Huffington Post...Paired with some looming rate increases for next year’s health plans, the abrupt departure of Aetna has triggered new worries that Obamacare ― a subsidized public-private system of health insurance plans competing for beneficiaries ― is in serious trouble and may even be unsustainable...It is very likely that we would need to leave the public exchange business entirely and plan for additional business efficiencies should our deal ultimately be blocked. Aetna CEO Mark Bertolini to the Department of Justice, July 5...To Obamacare critics, Aetna’s retreat is proof the law is failing. To supporters, it shows the company was using its participation in Obama’s signature domestic policy initiative as a bargaining chip in order to secure approval of a controversial business deal...
- Novartis continues to face a bribery probe in Turkey, after all (statnews.com)
Is Novartis being investigated for paying bribes in Turkey? This seems to depend upon who you ask...the drug maker told us that it had concluded an internal investigation and found the accusations were unsubstantiated. The allegations surfaced in March in a report that an anonymous whistleblower accused the drug maker of using a consulting firm to pay bribes so its medicines could be added to formularies (in government-run hospitals)...Novartis also said last week that, while it was cooperating with Turkish authorities, the investigation "really isn’t a confirmed issue." And the drug maker told Reuters that "we are not aware of any government authority investigating Novartis. We now consider this matter closed."...On Wednesday, though, an official at Turkey’s health ministry in Ankara told Reuters that an investigation into Novartis was still "ongoing"…Bribery allegations are, no doubt, a sensitive issue. To what extent Novartis management in Turkey is clearly communicating the facts on the ground to corporate headquarters remains to be seen. But in any event, Novartis would welcome any opportunity to put such charges behind it, especially given a recent spate of embarrassing incidents...
- Report Finds Orphan Drug Pricing Increased More With Higher Off-Label Use (morningconsult.com)
Almost half of a special group of drugs, defined as those developed to treat rare diseases, were used for other purposes, according to a new report by America’s Health Insurance Plans. The greatest price increases among this group of drugs — called orphan drugs — were for those used for purposes other than treating the rare diseases they were developed to target...The insurers’ report charged this behavior is yet another example of drug companies potentially gaming the system for profit, the latest development in the rhetorical war between insurers and drug companies over drug costs...Orphan drugs, long thought to be treating so few patients each year that they did not present a reimbursement challenge for payers, are now being more closely scrutinized by public and private payers…study found that of its sample of 46 orphan drugs...47 percent of the drugs’ usage was for non-orphan purposes...
- Why certain drugs don’t make the formulary (biopharmadive.com)
With the drug pricing debate raging over the last few years, the announcement of national formulary exclusions from pharmacy benefit managers is enough to send stocks spiraling. Recent announcements from Express Scripts and CVS Health have highlighted the competitive dynamic in certain markets and have stakeholders questioning why certain drugs are excluded in one place, but not another...So why the discrepancies? Is one of these drugs better than another? Safer?...Hardly – in many instances, there are only slight differences in administration or effectiveness. In most cases, the pharmacy benefit managers were just better negotiators – competition is leverage, and having leverage means you hold the power...exclusions only happen in categories with an increasing amount of competition, particularly classes that have multiple drugs that work similarly and with similar effectiveness...While many manufacturers like to believe in the benefits and differentiation of their products, very often, these benefits are highly nuanced and selective...manufacturers should really think about how they negotiate price if they're looking for the broadest patient populations...I (Susan Garfield, principal at EY's life science advisory practice) don’t foresee the fundamentals of pricing changing, but the levers that determine pricing could change. If a value paradigm is introduced and implemented in the U.S. it could create that predictability and structure...