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5 Things to Consider When Launching a New Drug: MMIT Meet the Expert webinar recap on Predicting Payer Uptake with Precision

Posted by MMIT on Apr 15, 2021

On April 6, MMIT kicked off a six-part Meet the Expert webinar series. The first session was focused on predicting payer uptake with precision. For example, many pharma manufacturers use analogs to predict payer uptake of a new drug being launched into the market. Tracking how an analog drug performed can help drug manufacturers improve messaging to payers, identify coverage challenges, and accurately predict payer uptake.

But choosing the right analogs can be challenging, said MMIT’s Carolyn Zele and Ritupriya Yamujala. Suppose the manufacturer’s drug is the first oral oncolytic for a particular tumor type. What criteria should the manufacturer consider in selecting an analog for comparison:

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Topics: Product Release, Payer, Branding & Marketing

Trends That Matter for Partial Orphan Drugs

Posted by Peter Johnson on Apr 8, 2021

A new study published in Health Affairs found that spending in the orphan drug category is overwhelmingly concentrated on so-called partial orphan drugs, which have both orphan and nonorphan indications. The study affirms growing concerns across the health care industry that drugmakers are misusing the orphan drug designation and introducing unwarranted cost into the drug channel, AIS Health reported.

The Orphan Drug Act of 1983 covers diseases that affect fewer than 200,000 people in the U.S., plus diseases that affect more than 200,000 people but are so expensive to treat that companies developing and marketing such therapies are not expected to recover their costs. With the designation, the FDA grants drugmakers expanded intellectual property and commercial rights intended to offset these steep costs.
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Topics: Industry Trends, Market Access, Product Release, Data & Analytics

Trends That Matter for New Heart Failure Drugs

Posted by Jane Anderson on Mar 25, 2021

Treatment for heart failure still relies significantly on tried-and-true generic drugs, but new brand-name entrants — including Novartis' Entresto (sacubitril/valsartan) and Amgen's Corlanor (ivabradine) — are important additions to prescribers' clinical arsenals against the high-mortality condition, industry insiders tell AIS Health.

"Generic heart failure drugs, including beta blockers, ACE inhibitors, and ARBs [angiotension receptor blockers] have historically been used and continue to be the backbone of therapy," says April Kunze, Pharm.D., senior director of clinical program development for Prime Therapeutics. "However, in the past few years, additional treatment options have become available. Entresto is now recommended as a first-line treatment option in patients with an ejection fraction <= 40%."
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Topics: Industry Trends, Market Access, Product Release, Data & Analytics

Radar On Market Access: Orphan Drug Act Has Been Overused, A New Study Shows

Posted by Peter Johnson on Mar 18, 2021

A new study published in Health Affairs found that spending in the orphan drug category is overwhelmingly concentrated on so-called partial orphan drugs, which have both orphan and nonorphan indications. The study affirms growing concerns across the health care industry that drugmakers are misusing the orphan drug designation and introducing unwarranted cost into the drug channel, AIS Health reported.

The Orphan Drug Act of 1983 covers diseases that affect fewer than 200,000 people in the U.S., plus diseases that affect more than 200,000 people but are so expensive to treat that companies developing and marketing such therapies are not expected to recover their costs. With the designation, the FDA grants drugmakers expanded intellectual property and commercial rights intended to offset these steep costs.

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Topics: Specialty, Industry Trends, Product Release, Data & Analytics

Trends That Matter for New Prostate Cancer Treatment

Posted by Angela Maas on Mar 11, 2021

People being treated for advanced prostate cancer now have a new oral option. On Dec. 18, the FDA approved Myovant Sciences GmbH’s Orgovyx (relugolix), a gonadotropin-releasing hormone (GnRH) receptor antagonist, to treat adults with advanced prostate cancer, AIS Health reported. Dosing for the drug is a loading dose of 360 mg on the first day of treatment and then 120 mg of the tablet once daily.

Treatment of advanced prostate cancer usually involves androgen deprivation therapy (ADT), and the current standard of care is luteinizing hormone-releasing hormone (LHRH) receptor agonists, such as leuprolide acetate, which is administered by a health care provider as an injection or implant. It is available as AbbVie Inc.’s Lupron Depot and Eligard from Tolmar Pharmaceuticals, Inc. to treat prostate cancer.
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Topics: Industry Trends, Market Access, Product Release, Data & Analytics

Radar On Market Access: FDA's Breyanzi Approval May Not Change NHL Management

Posted by Angela Maas on Mar 9, 2021

With the FDA's approval of Bristol Myers Squibb's Breyanzi (lisocabtagene maraleucel) last month, there are now three chimeric antigen receptor T cell (CAR-T) therapies to treat a certain type of non-Hodgkin’s lymphoma (NHL). A Zitter Insights poll shows that payers do not anticipate its approval as having much of an impact on their management of the space, AIS Health reported.

On Feb. 5, the FDA approved Breyanzi for the treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B.

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Topics: Industry Trends, Market Access, Product Release

Radar On Market Access: New Heart Failure Drugs Offer More Therapy Options

Posted by Jane Anderson on Mar 2, 2021

Treatment for heart failure still relies significantly on tried-and-true generic drugs, but new brand-name entrants — including Novartis' Entresto (sacubitril/valsartan) and Amgen's Corlanor (ivabradine) — are important additions to prescribers' clinical arsenals against the high-mortality condition, industry insiders tell AIS Health.

"Generic heart failure drugs, including beta blockers, ACE inhibitors, and ARBs [angiotension receptor blockers] have historically been used and continue to be the backbone of therapy," says April Kunze, Pharm.D., senior director of clinical program development for Prime Therapeutics. "However, in the past few years, additional treatment options have become available. Entresto is now recommended as a first-line treatment option in patients with an ejection fraction <= 40%."

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Topics: Industry Trends, Market Access, Product Release

Perspectives on Developments to Watch in Pharma

Posted by Leslie Small on Feb 18, 2021

In 2021, the three main "developments to watch" in the branded pharmaceuticals sector will include COVID-19 vaccine scale-up and distribution, continued legislative and regulatory pushback against high drug prices, and robust levels of merger and acquisition activity, according to a new report from Moody's Investors Service.

Regarding vaccines, Moody's noted that Moderna Inc. as well as Pfizer Inc. and its partner BioNTech will continue to ramp up production of their COVID-19 vaccines and distribute them widely throughout 2021.
 
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Topics: Industry Trends, Product Release, Data & Analytics, Payer

Trends That Matter for Prevention of HAE Attacks

Posted by Jane Anderson on Feb 11, 2021

When the FDA approved BioCryst Pharmaceuticals, Inc.'s Orladeyo (berotralstat) in December 2020, the drug became the first oral treatment for prophylaxis to prevent hereditary angioedema (HAE) attacks, AIS Health reported. According to Zitter Insights, payers with nearly three-quarters of covered lives plan to manage it at parity to other prophylactic treatments.

The FDA approved the first drug to treat HAE, Shire plc's Cinryze (C1 esterase inhibitor [human]), on Oct. 10, 2008. Since then, the FDA has approved eight drugs to treat HAE: half for acute attacks and half for prophylaxis.
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Topics: Market Access, Product Release, Data & Analytics

Radar On Market Access: New Prostate Cancer Treatment Orgovyx Offers Oral Option

Posted by Angela Maas on Feb 11, 2021

People being treated for advanced prostate cancer now have a new oral option. On Dec. 18, the FDA approved Myovant Sciences GmbH’s Orgovyx (relugolix), a gonadotropin-releasing hormone (GnRH) receptor antagonist, to treat adults with advanced prostate cancer, AIS Health reported. Dosing for the drug is a loading dose of 360 mg on the first day of treatment and then 120 mg of the tablet once daily.

Treatment of advanced prostate cancer usually involves androgen deprivation therapy (ADT), and the current standard of care is luteinizing hormone-releasing hormone (LHRH) receptor agonists, such as leuprolide acetate, which is administered by a health care provider as an injection or implant. It is available as AbbVie Inc.’s Lupron Depot and Eligard from Tolmar Pharmaceuticals, Inc. to treat prostate cancer.

Read More

Topics: Industry Trends, Market Access, Product Release