- Blame Game Over High Drug Prices Escalates With New Ad (bloomberg.com)
New punches were thrown in the blame game over U.S. drug prices...Broadening its efforts to defuse outrage over skyrocketing prices, Pharmaceutical Research and Manufacturers of America...started an advertising campaign urging insurers to share with customers more of the benefits of rebates they’ve negotiated. In response, the main health-insurance lobby pushed the blame back on drugmakers: "Enough with the distractions."...Meanwhile, the head of one of the largest pharmacy benefit managers, who are often criticized by drugmakers for their lack of transparency, said his industry helps save money and manufacturers should stop faulting the middlemen...The new ad from PhRMA...is another step in its endeavor to demonstrate that other parts of the health-care industry are responsible for the costs faced by patients. In January, the group started a major initiative, including TV, radio and digital ads.
- Opaque System
- Price Negotiations
- ‘Losing Strategy’
- Pharmacy Week in Review: April 7, 2017 (pharmacytimes.com)
Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- Sanofi Pasteur coughs up $19.8M to settle claims it overbilled the VA (fiercepharma.com)
Sanofi Pasteur agreed to pay more than $19.8 million to settle allegations that it overcharged the Department of Veterans Affairs for its products...The French pharma’s vaccines unit voluntarily reported the "calculation and reporting error" with the VA in 2012, and has since "cooperated fully and negotiated in good faith with the government,"...Sanofi Pasteur based its first disclosure to the U.S. government on products sold to the VA from 2007 to 2011. A follow-up investigation by the VA's Office of Inspector General found the overcharging error dated back to 2002, the DOJ said…This is not the first settlement in a pharma overpricing case. A range of drugmakers have paid settlements to wrap up improper billing allegations, which often fall under the False Claims Act, which governs overcharging for Medicare, Medicaid and other government programs. The most prominent recent case was Mylan’s $465 million deal to settle allegations that it overcharged Medicaid for EpiPens...
- 5 Takeaways From the AMCP Annual Meeting (ajmc.com)
At the Academy of Managed Care Pharmacy Annual Meeting, held March 27-30...in Denver...the cost of healthcare was on everyone’s minds and was a common thread in most sessions...Here are 5 key takeaways from the meeting.
- Value frameworks were on people’s minds...AMCP sees value frameworks as a tool that can help with the formulary decision making process…
- They are increasingly being used by payers...a survey of payers from the beginning of 2016 found that 26% were currently using value frameworks and an additional 22% planned to use them in the next 12 months. Only 19% had no plans to use value frameworks…
- Frameworks are just 1 solution centering on value…the National Pharmaceutical Council, outlined 3 other solutions that center around value. These include value-based insurance design, value-based contracting, and financing...
- Change is coming to healthcare...L.E.K. Consulting, followed the money in healthcare and came to the conclusion that healthcare is an unsustainably big business, which necessitates change.
- Obamacare repeal isn’t the only legislation to watch...Republicans may not have gotten the American Health Care Act, which would repeal and replace the Affordable Care Act, through the House of Representatives, but there could be future efforts to bring the legislation back in another form…
- The government’s struggle to hold opioid manufacturers accountable (washingtonpost.com)
Sixty-six percent of all oxycodone sold in Florida came from this company. But the DEA’s case against it faltered...Mallinckrodt’s blue 30-milligram oxycodone tablets became so popular among drug users and dealers that they acquired a street name — "M’s," for the company’s distinctive block-letter logo…the Drug Enforcement Administration trained its sights in 2011 on Mallinckrodt Pharmaceuticals, one of the nation’s largest manufacturers of the highly addictive generic painkiller oxycodone. ..It was the first time the DEA had targeted a manufacturer of opioids for alleged violations of laws designed to prevent diversion of legal narcotics to the black market. And it would become the largest prescription-drug case the agency has pursued…But six years later, after four investigations that spanned five states, the government has taken no legal action against Mallinckrodt. Instead, the company has reached a tentative settlement with federal prosecutors…Under the proposal…Mallinckrodt would agree to pay a $35 million fine and admit no wrongdoing.
- Failure to Reauthorize User Fee Programs Would Result in About 3,000 FDA Layoffs (raps.org)
Representatives from the biotechnology, medical device and generic drug industries told members of the Senate Committee on Health, Education, Labor & Pensions...that if the five-year user fee programs are not reauthorized, the US Food and Drug Administration would likely see more than 3,000 job cuts...Those layoffs...would significantly curtail new medical product approvals for pharmaceutical, biotech and medical device companies and likely delay research...Senators on both sides of the aisle also criticized Trump’s budget proposal on Tuesday, which would cut billions from the National Institutes of Health and replace congressional appropriations at FDA with more user fees...Representatives from industry groups BIO, AdvaMed and AAM reiterated to the committee what FDA officials told the House Energy & Commerce Committee late last month: that a failure to act on the already-agreed-to reauthorizations would be devastating...
- 20,000 leagues for biotech to explore (biopharmadive.com)
The sea covers around 70% of the earth, and contains around 97% of the world's water. It's also home to almost 240,000 species...as a resource, it is still untapped...Bioprospecting is the discovery and development of new products based on resources from the natural world...We are not marine organisms, so until about 1970, no one even thought of the ocean. It was left as a deep secret. It seemed ridiculous to me that the ocean — with such a vast habitat — had escaped anyone's notice. But there are good reasons. People fear the ocean; it has been considered a very hostile, inhospitable place...the history of drugs from the sea isn't particularly long. Red algae have traditionally been used to make a treatment for colds, sore throats, chest infections including tuberculosis, kidney trouble, burns, cancer and indigestion...There are plenty of high-profile drugs that have gotten their origins from the sea…There are more than 25 marine-derived molecules in clinical trials, with over a thousand in pre-clinical development...There are still many societal challenges that the marine environment could help us to meet, such as antibiotic resistance...It is a source of chemical diversity, with novel targets and novel modes of action...
A snapshot of late stage development:
- PharmaMar...Plitidepsin and lurbinectedin, both derived from sea squirts... T-cell lymphoma...
- BeyondSpring...linabulin...is based on a marine fungus…non-small cell lung cancer...
- Ohr Pharmaceutical...Squalamine...found in dogfish shark tissues...a wide variety of indications…antimicrobial against bacteria, fungi, protozoa and viruses, as well as in cancer, macular degeneration, diabetic retinopathy and fibrodysplasia ossificans progressive...
- Wex Pharmaceuticals...puffer fish...neurotoxin tetrodotoxin...a non-addictive and rapid-acting pain killer without opioid-like side effects....
- Uruguay gives pharmacies green light to start selling marijuana (reuters.com)
Uruguay's three-year process of legalizing recreational cannabis consumption reached its final stage...when the government said it would authorize pharmacies to begin selling the substance as of July...Sixteen pharmacies have registered with the government of the tiny South American country to be able to sell marijuana for recreational purposes. That number is expected to increase to 30 in the coming months, said Juan Roballo, head of the National Drug Board...The government hopes the formalization process will "guarantee the quality and the purity of the product" citizens consume, Roballo said. The cannabis sold in pharmacies will be grown by producers licensed by the state...The process will be heavily regulated by the government...Interested Uruguayans 18 or older must enroll in a government registry...and are limited to purchasing 40 grams per month…
- Latest Data Show That Hospitals Are Still Specialty Drug Profiteers (drugchannels.net)
The new 2016 Medical Pharmacy Trend Report??...released...As always, the report includes a boatload of useful data on medical benefit spending and claims….Unfortunately, the latest edition also shows how hospitals continue to earn outrageous profits on specialty drugs. Commercial payers still use reimbursement approaches that permit hospitals to inflate specialty drug costs by thousands of dollars per claim...These hospital mark-ups translate directly into higher drug spending—regardless of how manufacturers set list prices. Using some fairly conservative assumptions about Remicade, I show below how hospitals are earning thousands of dollars more than the drug’s manufacturer does...Meanwhile, health plans are struggling to shift patients from hospital outpatient settings to physician offices—where costs are lower, at least until those sites are acquired by hospitals.
- Arizona Enacts Law: Pharmaceutical Companies to Legally Communicate Off-Label Treatment to Medical Professionals (policymed.com)
...pharmaceutical companies are not permitted to discuss off-label, legal, alternative uses for an approved drug with physicians and other healthcare professionals as regulated by the FDA. However, a bill in Arizona, HB 2382 that passed unanimously (The Free Speech in Medicine Act) has changed that...Governor Doug Ducey signed the bill into law, lifting the aforementioned off-label promotion restriction and allowing drug companies to communicate with doctors and other healthcare providers about safe and effective alternative uses for approved prescription drugs...The law...safeguards the free speech rights of pharmaceutical industry members to share truthful research and information about FDA-approved medicines...HB 2382...only protects the sharing of information that is "not misleading, not contrary to fact, and consistent with generally accepted scientific principles;" and it only applies to communication between pharmaceutical manufacturers and licensed healthcare professionals. The bill does not permit pharmaceutical manufacturers to advertise off-label uses directly to the public...Since Arizona enacted this protection for industry, it is likely to expand options in doctors’ toolkits, enhance patient autonomy, and increase access to healthcare. It will be interesting to see if any other states will follow suit and implement similar laws...