CMS Sets Date for Medicare Drug Price Negotiation Final Guidance for July
The US Centers for Medicare and Medicaid Services (CMS) will aim to release the final draft guidance on the upcoming Medicare drug pricing negotiations instantiated by the passage of the Inflation Reduction Act. The draft guidance was released last month and is currently open for comments. The agency, according to its administrator Chiquita Brooks-Lasure, has already begun talks with manufacturers.
ICER Releases Draft Guidance Supporting Cost-Effectiveness of $2 Million Sickle Cell Gene Therapy
The Institute of Clinical and Economic Review (ICER) has issued a draft guidance supporting the use of two different gene therapies for sickle cell disease. The treatments, developed by Vertex and CRISPR Therapeutics, both run around $2 million per treatment, but ICER argues that the high price tag could be cost effective in some cases.
FDA Mulling Over Next Move Following Mifepristone Ruling
The US Food and Drug Administration’s authority to approve medications is on the line, following a Texas judge shooting down the decades-old approval of the abortion medication mifepristone. With this development, the agency is looking for ways to preserve its powers while keeping mifepristone on the market. The strategy will depend on an appeal at the Fifth Circuit tomorrow.
Drug Purchasing Group Sues Takeda Over Gout Drug Pay-For-Delay Deal
Takeda is once again in hot water over allegations it participated in a pay-for-delay deal, this time over its gout drug Colcrys. The plaintiffs, a group of drug distributors, claim that Takeda patent settlements with several generics manufacturers delayed the release of cheaper alternative, preventing price drops for the millenia-old drug.
Real-World Data Study Shows Biosimilar Rituximab for Rheumatoid Arthritis Safe and Effective
A new real-world data (RWD) study published in Rheumatology International found that patients with rheumatoid arthritis who switched from Roche’s biosimilar rituximab to Rixathon’s version of the biosimilar did not suffer any deterioration. Patients who had not taken any version of rituximab also saw similar benefits.
Pharma and FDA Wary of Dueling Texas and Washington Abortion Pill Rulings
Last week’s ruling in a US federal court that struck down the decades-old approval of mifepristone, a key drug in the abortion pill, has the US Food and Drug Administration (FDA) and the entire pharma industry on edge. The ruling, according to some legal experts, would undermine the agency’s ability to independently approve drugs based on scientific evidence. Another ruling last Friday ordered the FDA to continue providing the drug to 17 states.
Mark Cuban’s Pharmacy Offers Invokana
Mark Cuban’s Cost Plus Drug Company has announced it now offers Invokana, an SGLT-2 inhibitor used to manage diabetes. The mail-order pharmacy will now provide a total of three brand name versions of the drug, Invokana, Invokamet, and the combination therapy Invokamet XR, which pairs the drug with metformin.
5 Tips for Achieving Reimbursement for Digital Health Solutions
The reimbursement landscape has shifted notably during the pandemic, opening pathways for digital health technologies and telehealth services. However, achieving reimbursement status can be challenging, especially considering the uncertainties surrounding the process. In a new Mobi Health News article, Timothy Lee and Dr. Liz Kwo give 5 takeaways to help digital health developers navigate this new environment. The first tip is to work with self-insured employers.
US HHS Secretary Becerra Warns Texas Abortion Pill Ruling Could Imperil Entire FDA Approval Process
Following a ruling invalidating the approval of mifepristone, a key component of the abortion pill, US Health and Human Services Secretary Xavier Beccera noted that such a decision undermines the Food and Drug Administration’s authority to approve therapeutics. Beccera said that the decision could let judges make the final call on whether drugs are approved, which may be weaponized against politically polarized drugs like COVID vaccines or new Alzheimer’s drugs.
Washington Judge Rules FDA Cannot Rollback Abortion Pill Access
The same day that a Texas judge issued a ruling invalidating the US Food and Drug Administration’s (FDA’s) decades long approval of mifepristone, a key component of the abortion pill, a federal judge in Washington state ruled that the FDA may not roll back access to the drug in 17 states. The ruling , delivered by US District Court Judge Thomas Rice, is in direct opposition by the nationwide ruling issued in Texas.
US Democrats Prepare Bill to Combat Abortion Pill Ruling
In response to a ruling by US District Court Judge Matthew Kacsmaryk that invalidated the 20-year-old approval of mifepristone, a key component of the abortion pill, US House Democrats have begun preparing a bill that would codify the agency’s right to approve the drug. The bill, which will likely face stiff resistance from the Republican House majority, was announced by representatives Pat Ryan (D-NY) and Lizzie Fletcher (D-Texas).
Texas Judge Cancels FDA Approval of Key Abortion Pill Component
US District Court Judge Matthew Kacsmaryk issued a ruling invalidating the decades-old approval of a key component of the most common form of abortion pill in the US, mifepristone. The ruling, which fell in favor of anti-abortion activists, ends not only the initial approval by the US Food and Drug Administration (FDA) but also recent policies meant to expand access to the drug. The move, some lawmakers, abortion rights advocates, and legal experts content, would undermine the agency’s independence.
NHS to Cover Lynparza for Breast and Prostate Cancer
Shortly after a recommendation from the UK’s National Institute for Care and Health Excellence (NICE), the NHS agreed to provide Lynparza, Merck and AstraZeneca’s prostate and breast cancer drug, to patients in Wales and England. The move comes after positive results showing the drug lowered mortality in breast cancer patients by a third.
US Senators Propose Bill to Cap Insulin Costs for Every Patient
US Senators Raphael Warnock (D-GA) and John Kennedy (R-LA) have advanced a new bill that would lock the max price of insulin at $35 a month for all patients. The bill, entitled the Affordable Insulin Now Act of 2023, comes after manufacturers have voluntarily lowered insulin prices following price caps for Medicare patients in the Inflation Reduction Act.
NICE Declines to Recommend Cabometyx for Thyroid Cancer Treatment
In a new draft guidance, the UK’s National Institute for Health and Care Excellence (NICE) decided against recommending Ipsen’s small molecule drug Cabometyx (cabozantinib) for the treatment of differentiated thyroid cancer (DTC). The recommendation comes after approval for the indication was made last year.
Most Accelerated Approval Confirmatory Studies are Turned in Late
Accelerated approval by the US Food and Drug Administration (FDA) requires drug and device manufacturers to conduct confirmatory studies to support full approval. A newly published paper in JAMA Health Forum found that over half of these studies are turned in late to the agency. These delays were more common in trials for small molecule drugs and non-oncologic therapeutics
FDA Plans to Authorize Additional Omicron Booster for Select Populations
A report by the Washington Post indicates that the US Food and Drug Administration is set to approve another round of boosters for adults 65 and up. The approval will also include adults who are immunocompromised. Boosters will be available for these patients for free 4 months after their last booster.
Novo Nordisk’s Wegovy Nabs CHMP Recommendation for Use in Teens
The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended the Novo Nordisk weight-loss medication Wegovy (semaglutide) for use in adolescents 12 and up. The move comes after a phase 3 trial showed the drug to be effective teens, with almost 3/4ths of participants losing 5% of their body weight.
EU Preps for Drug Law Overhaul
The EU is preparing legislation that would overhaul the pharmaceutical industry with a series of reforms targeting drug prices, transparency, and intellectual property (IP). Under the legislation, drugmakers would have a reduced exclusivity period for new drugs, which can be ameliorated by launching a drug in all member states simultaneously. In addition, the laws would simplify the regulatory approval process.
CMS Trims Down List of Drugs Targeted for Price Hike Penalties
The US Centers for Medicare and Medicaid Services (CMS) has pulled 7 drugs from its list of medicines facing penalties for drug price hikes. The Inflation Reduction Act included a provision that would penalize drug manufacturers for raising the price of drugs faster than inflation. This brings the total down to 20 drugs.
European Commission Approves BMS’ New Plaque Psoriasis Drug
Bristol Meyer Squib (BMS) has scored a win with the European Commission (EC) approval of Sotyktu, its new treatment for plaque psoriasis. The treatment would be the first of its kind, an oral allosteric tyrosine kinase inhibitor. The approval covers adults with moderate-to-severe psoriasis that may benefit from systemic treatment for the disease.
NICE Issues Final Draft Guidance Recommending Tezspire for Severe Asthma
The UK’s National Institute for Health and Care Excellence (NICE) released a final draft guidance recommending the use of Amgen and Astrazeneca’s Tezspire in maintenance treatment for some patients with severe asthma. The biologic is the only one of its kind, targeting an important asthma-related inflammatory protein.
PBMs Catch Heat from Both Parties in US Senate Finance Committee Hearings
US Senators from both sides of the aisle put forward several ideas on how to reform the pharmacy benefit manager (PBM) industry, which negotiates drug prices and coverage decisions between pharma, payers, and pharmacies. Although the senators acknowledged that PBMs cut prices for many patients, they lambasted the industry’s lack of transparency and practices that raise costs for older adults enrolled in Medicare part D.
Narcan Goes OTC in the US
The US Food and Drug Administration (FDA) has approved over-the-counter (OTC) sales of Narcan (naloxone), a drug used to immediately treat an opioid overdose. The drug could previously be prescribed and sold at many pharmacies, but the OTC designation should expand the reach of the drug to more pharmacies and people who may use the drug on others.
Three Major FDA Adcomms on the Horizon
As May approaches, the US Food and Drug Administration (FDA) is planning for three advisory committees that have major implications for healthcare in the US. The first will review Perrigo’s over-the-counter contraceptive. Next, a committee will examine an intranasal epinephrine spray for severe asthma. The final will focus on a yet unnamed product from Intarcia Therapeutics.
