PHARMACY

Industry groups urge members to submit DIR comments to CMS by Jan. 25

BY Sandra Levy

The National Association of Chain Drug Stores and the National Community Pharmacists Association are urging member companies to submit official comments to the Centers for Medicare & Medicaid Services in support of direct and indirect remuneration, or DIR fee, reform concepts described in the agency’s proposed rule, “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses.”

The deadline to submit comments is Jan. 25 at 5 p.m. EST.

NACDS said it encourages members to convey in their comments that DIR fee reform is vital for helping to reduce patients’ out-of-pocket drug costs at the pharmacy counter, and for the viability of pharmacy patient care and the value that this care creates in the form of reductions in overall healthcare costs.

Members also should urge CMS to take swift action on the DIR fee reform aspects of “file code CMS-4180-P – and to assure that DIR fee reform is implemented for plan year 2020,” NACDS said.

NCPA is directing members and patients to visit its home page at www.ncpanet.org and click on #FixDIR to submit comments.

Other tips for submitting impactful comments include the following: reference file code CMS-4180-P at the top of your company’s comments; review the detailed submission instructions outlined on the first page of the proposed rule and ensure sufficient time for mailed submissions to arrive by Jan. 25; and share with NACDS an electronic copy of your company’s comments by emailing the document to [email protected]

For further information, NACDS members can contact Tom O’Donnell, NACDS’ senior vice president of government affairs and public policy, at (703) 837-4216 or at [email protected]

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Acorda Therapeutics’ Inbrija gets approval

BY Sandra Levy

Acorda Therapeutics has received the Food and Drug Administration’s green light for Inbrija for intermittent treatment of OFF episodes in people with Parkinson’s disease treated with carbidopa/levodopa.

OFF episodes, or OFF periods, are defined as the return of Parkinson’s symptoms that result from low levels of dopamine between doses of oral carbidopa/levodopa, the standard oral baseline Parkinson’s treatment.

“Today’s approval of Inbrija marks a major milestone for both Acorda and the Parkinson’s community, for whom we are gratified to have developed this much-needed therapy,” Acorda president and CEO Ron Cohen said. “This milestone resulted from over two decades of research and development, beginning in the laboratory of Dr. Robert Langer at Massachusetts Institute of Technology, through years of enormous perseverance and ingenuity by the entire Acorda team.”

Inbrija, which is expected to be available in the first quarter of 2019, will be distributed through a network of specialty pharmacies.

“Despite being on treatment, patients may experience OFF periods as Parkinson’s progresses, which can be disruptive,” The Michael J. Fox Foundation’s CEO, Todd Sherer, said. “The foundation provided funding for the early clinical development of Inbrija because patients told us that OFF periods were one of their most serious issues. We knew we had to help address this unmet need, and this approval is a significant step forward for the community as it provides a new option to manage these gaps in symptom control.”

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Amgen’s Nplate pediatric indication gets FDA approval

BY Sandra Levy

Amgen has received the Food and Drug Administration’s blessing for Nplate (romiplostim) for the treatment of pediatric patients age 1 year old and older with immune thrombocytopenia, or ITP, for at least six months who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

ITP is a rare, serious autoimmune disease characterized by low platelet counts in the blood and impaired platelet production.

Nplate is a thrombopoietin, or TPO, receptor agonist that mimics the body’s natural TPO, and is designed to increase platelet counts in patients with chronic IPT.

“Today’s approval underscores our long-standing commitment to making a positive impact on the lives of patients with rare and difficult to treat hematological disorders,” David Reese, Amgen’s executive vice president of research and development, said. “In the 10 years since the FDA approved Nplate as the first platelet booster for adult patients with chronic ITP, it has made a difference in the lives of thousands of adults, and we’re proud to bring this treatment option to children who need it most.”

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