The regulatory agency found deficiencies in its inspection of Alvotech’s Reykjavik, Iceland, facility. The company plans to resubmit its application once these are addressed.
Formulary Watch
Latest News
All News
Advertisement
The two-drug regimen of Braftovi and Mektovi was approved to treat patients who have a subset of non-small cell lung cancer, those with a BRAF V600E mutation.
Yuflyma is on Ventegra’s public and private formulary on parity with the reference product Humira.
Insurers and PBMs now have to follow a 2020 rule in which accumulator programs can only be applied to brand name drugs that have generic equivalents available.
Inpefa is an inhibitor of both SGLT2 and SGLT1, approved to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. The wholesale acquisition cost is $598 per month.
The IV formulation has a wholesale acquisition cost of $2,115 per vial and will be available in the fourth quarter.
Alnylam Pharmaceuticals will no longer pursue this indication of Onpattro and will instead on focus on a label expansion for Amvuttra, which is in phase 3 development to treat patients with cardiomyopathy of ATTR amyloidosis.
The dosage of Zoryve for children 6 to 11 is the same as for those over the age of 12. The list price is same for both pediatrics and adults — $825 per tube.
Patients who continued with their rheumatoid arthritis biologic medication tended to spend less on healthcare, had a lower chance of being hospitalized, and had shorter hospital stays.
Advertisement
Issues related to finding from an FDA inspection at a third-party filler have been resolved.
Mark Campbell, Pharm.D., RxBenefits’ senior vice president of clinical solutions, talks about how Medicare’s drug price negotiations could have a ripple effect on pharmaceutical company innovation and prices on the commercial side.
Betaxolol may cause a slowing in the heart rate in some patients; an opioid could increase the effect.
Galderma officials said they have already identified changes to its manufacturing process for relabotulinumtoxinA, which is being reviewed as a treatment for frown lines and crows feet.
ICER has weighed in on two of the 10 drugs selected for negotiations: Eliquis and Xarelto, which are among Medicare Part D’s highest spending drugs.
Once Medicare’s negotiated price for prescription drugs goes into effect, payers have more of an incentive to steer patients to lower-cost alternatives.
In a confirmatory trial, Exkivity did not meet the primary endpoint in treating patients with non-small cell lung cancer with EGFR exon 20 mutations. It will remain available while Takeda works with the FDA on withdrawal timing.
FDA has set an action date of March 31, 2024, for marnetegragene autotemcel to treat infants with a serious and often fatal immunodeficiency.
Biogen is still evaluating launch timeline for Tofidence, and information on pricing will be available closer to launch.
Aetna, Cigna, Humana, United Healthcare — some of the largest providers of Medicare Advantage plans — have released updates to prescription drug programs.
At issue are findings from the agency’s inspection of a third-party manufacturing company. The FDA indicated there were no concerns about the safety or labeling of lebrikizumab.
The two-component therapy of Pombiliti plus Opfolda to treat adults living with late-onset Pompe disease will have an annual list price of $650,000.
Odronextamab is a bispecific antibody to treat relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma. The target action date is March 31, 2024.
The recent study also found that Jardiance for patients with heart failure with preserved ejection fraction could be cost-effective if discounted by 29%.
Contamination of Brexafemme with a non-antibacterial beta-lactam drug could lead to reactions such as swelling, rash, urticaria and anaphylaxis.
Exxua is approved to treat adults with major depressive disorder, but its labeling does not contain warnings about sexual function or weight gain.
Advertisement
Advertisement
