Product Release

Radar on Market Access: Crowded Pipeline Could Bring More Competition to Atopic Dermatitis Space

May 18, 2021

Dupixent (dupilumab), the first biologic approved for atopic dermatitis (AD), hasn’t shaken up treatment of the condition completely even as it steadily gains market share, since the bulk of plans still require patients to try mostly generic topical drugs first. But more competition could be coming to this category, with the FDA set to consider four new products for AD, including three Janus kinase (JAK) inhibitors, AIS Health reported.

The FDA extended the review period to early in the third quarter of 2021 for Pfizer Inc.’s abrocitinib for the treatment of adults and adolescents with moderate to severe AD. The agency also extended review to the third quarter of Eli Lilly and Co.’s and Incyte’s supplemental New Drug Application for Olumiant (baricitinib) for the treatment of adults with moderate to severe AD, saying it wants to gather additional cost-benefit and safety data.

Dupixent (dupilumab), the first biologic approved for atopic dermatitis (AD), hasn’t shaken up treatment of the condition completely even as it steadily gains market share, since the bulk of plans still require patients to try mostly generic topical drugs first. But more competition could be coming to this category, with the FDA set to consider four new products for AD, including three Janus kinase (JAK) inhibitors, AIS Health reported.

The FDA extended the review period to early in the third quarter of 2021 for Pfizer Inc.’s abrocitinib for the treatment of adults and adolescents with moderate to severe AD. The agency also extended review to the third quarter of Eli Lilly and Co.’s and Incyte’s supplemental New Drug Application for Olumiant (baricitinib) for the treatment of adults with moderate to severe AD, saying it wants to gather additional cost-benefit and safety data.

Meanwhile, the FDA requested additional data on LEO Pharma A/S’s biologic tralokinumab, intended for adults with moderate to severe AD, but only on a device component, not on efficacy or safety, the company said in April. Tralokinumab would offer a novel mechanism of action for AD, noted the latest quarterly Drug Pipeline Insights Report from UnitedHealth Group’s OptumRx, although it also pointed out that “efficacy appears more modest than competing existing treatment options like Dupixent.”

Finally, a topical JAK inhibitor, Incyte’s ruxolitinib, was accepted for FDA priority review in February, with a target FDA action date in late June.

“The new oral and injectable therapies may bring new formulary options compared to Dupixent,” says Mesfin Tegenu, CEO and chairman at RxParadigm. “Depending upon how these new products are priced, market forces may play a role to bring down the annual cost for Dupixent. However, for any responsible prescriber there’s an abundance of generic topical corticosteroids available for treatment.”

At Prime Therapeutics, Dupixent is preferred on the PBM’s standard formulary as a specialty medication, says April Kunze, Pharm.D., senior director of clinical program development. It is subject to utilization management, Kunze says, adding, “there has been more awareness to this category, and biologics such as Dupixent have been approved with good efficacy results.”

Meanwhile, Eucrisa (crisaborole), a steroid-free topical treatment from Anacor Pharmaceuticals, Inc., is preferred on Prime’s standard A-Series NetResults formulary with no utilization management in place, Kunze adds.

The newer agents are unlikely to shake up treatment of most patients, according to Tegenu. “Treatment starts with the more conventional options, as there is much more data available and cost is significantly lower,” he says.

by Jane Anderson

 

Radar On Market Access: So Far, New Therapies Have Limited Impact on ADHD Management

April 27, 2021

In recent months, some innovative treatments have emerged for attention deficit hyperactivity disorder (ADHD), which affects millions of children and is one of the most common neurodevelopmental disorders in childhood. But because those therapies are so new — and in one case, very unconventional — payers appear reticent to change their coverage tactics to accommodate them, AIS Health reported.

On April 2, the FDA approved Supernus Pharmaceuticals, Inc.’s Qelbree (viloxazine extended-release capsules) for treating ADHD in patients ages 6 to 17 — a therapy that “represents the first novel non-stimulant treatment for ADHD in a decade,” according to the manufacturer.

In recent months, some innovative treatments have emerged for attention deficit hyperactivity disorder (ADHD), which affects millions of children and is one of the most common neurodevelopmental disorders in childhood. But because those therapies are so new — and in one case, very unconventional — payers appear reticent to change their coverage tactics to accommodate them, AIS Health reported.

On April 2, the FDA approved Supernus Pharmaceuticals, Inc.’s Qelbree (viloxazine extended-release capsules) for treating ADHD in patients ages 6 to 17 — a therapy that “represents the first novel non-stimulant treatment for ADHD in a decade,” according to the manufacturer.

“Qelbree may bring competition to the non-stimulant ADHD market if it continues to show promising data of earlier onset of action compared to Strattera,” says Mesfin Tegenu, R.Ph., CEO of RxParadigm. Both Qelbree and Eli Lilly and Co.’s Strattera (atomoxetine), which are non-stimulants, have the advantage of avoiding the abuse and addiction risks posed by other ADHD therapies like Ritalin (methylphenidate) and Adderall (amphetamine/dextroamphetamine).

“Based on current Phase III studies, Qelbree began to show improvement after the first week of therapy through the end of the study at week 7, while Strattera requires 4 to 8 weeks to begin working,” Tegenu points out. Ultimately, he adds, “more information will be needed before we see a shift in payers’ attitude towards Qelbree.”

Qelbree is not the only new ADHD treatment to make headlines in the last year. In June 2020, the FDA approved the “first game-based digital therapeutic device to improve attention function in children with ADHD.” The EndeavorRx device, manufactured by the Canadian company Ehave, Inc., is available only by prescription and is designed for patients between 8 and 12 years old who are primarily inattentive or combined-type ADHD with a demonstrated attention issue. The device currently is not covered by health insurance, according to the EndeavorRx website, although the manufacturer said it is trying to change that.

Even with these new treatments coming to market, Tegenu points out that behavioral therapy is generally recommended as the first-line treatment for preschool-age children who have been diagnosed with ADHD. That may be “followed by the addition of methylphenidate based on tolerability profile, if warranted,” he says.

Similar to their younger counterparts, children and adolescents who are in elementary school and older “may receive behavioral therapy and stimulant medication to help achieve target goals and improve symptoms,” Tegenu adds.

by Leslie Small

 

Trends That Matter for Partial Orphan Drugs

April 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.

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.

The new paper found that 70.7% of spending on drugs designated as orphan drugs went “to nonorphan indications,” and noted that in 2017, 25% of U.S. prescription drug spending was for orphan drugs.

Ge Bai, Ph.D., an associate professor at Johns Hopkins University’s Carey Business School and Bloomberg School of Public Health, asserts that the orphan drug designation is being abused by drug companies.

“They [orphan drugs] treat a small number of patients, but at the same time they can be used to treat much more common diseases. So they [drugmakers] can still charge a high price and take the tax credit, while at the same time enjoying their impressive commercial success,” Bai says.

Bai adds that drugmakers have become adept at coordinating outside pressure to convince the FDA to expand orphan drug designations beyond their intended purpose.

Trends That Matter for New Heart Failure Drugs

March 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%."

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%.”

Novartis said Feb. 16 that Entresto won an expanded indication from the FDA to reduce the risk of cardiovascular death and hospitalization in adult patients with chronic heart failure. “Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal,” the drugmaker said.

Prime Therapeutics currently prefers Entresto on formulary, and the PBM recommends that plans remove prior authorizations for Entresto in order to encourage its use, Kunze says.

Mesfin Tegenu, CEO and chairman of RxParadigm, says that Entresto, which has an average retail price of around $600 per month, typically is placed on formularies as a preferred brand drug. Meanwhile, Amgen’s Corlanor can be beneficial in reducing heart failure-associated hospitalization for patients with symptomatic (NYHA Class II-III) stable chronic heart failure with a left ventricular ejection fraction of less than or equal to 35% who are receiving a maximal tolerated targeted dose of a beta blocker and in sinus rhythm with a heart rate of 70 beats per minute or greater at rest, Tegenu says.

The graphic below show how key chronic heart failure medications are covered among commercial health plans, health exchange programs, Medicare and Medicaid programs under the pharmacy benefit.

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

March 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.

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.

The new paper found that 70.7% of spending on drugs designated as orphan drugs went “to nonorphan indications,” and noted that in 2017, 25% of U.S. prescription drug spending was for orphan drugs.

Ge Bai, Ph.D., an associate professor at Johns Hopkins University’s Carey Business School and Bloomberg School of Public Health, asserts that the orphan drug designation is being abused by drug companies.

“They [orphan drugs] treat a small number of patients, but at the same time they can be used to treat much more common diseases. So they [drugmakers] can still charge a high price and take the tax credit, while at the same time enjoying their impressive commercial success,” Bai says.

Bai adds that drugmakers have become adept at coordinating outside pressure to convince the FDA to expand orphan drug designations beyond their intended purpose.

“We have so many patient advocacy groups — they are representing rare disease patients. And many of those advocacy groups are heavily sponsored by drug manufacturers,” Bai says. “You cannot just single out the drugs that are being most abused — because even those drugs do have orphan drug features….It’s very hard to disentangle.”

Similarly, Avalere Health’s Lilian Buch and David Kowalsky observed during a Feb. 26 podcast that the orphan drug advocacy work that manufacturers coordinate with patients does serve an important purpose and can improve patient outcomes on an individual basis. Kowalsky is director of the consulting firm’s commercialization and regulatory strategy practice, while Buch is an associate principal in the same practice.

Buch added that, for some rare disease patients with acute symptoms, drug manufacturers sometimes offer the kind of support services more often provided by plans or providers.

Trends That Matter for New Prostate Cancer Treatment

March 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.

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.

For the Managed Care Oncology Index: Q3 2020, between Aug. 26, 2020, and Sept. 30, 2020, Zitter surveyed 50 commercial payers about their anticipated management of Orgovyx within six months of availability. Those with 89% of covered lives said they were likely to manage the drug to label.

During the same time frame, Zitter surveyed 100 oncologists, and 77% said they were likely to prescribe Orgovyx, with 62% saying they were likely to prescribe the new drug over leuprolide acetate. Almost half of respondents indicated they are likely to transition patients on leuprolide acetate to Orgovyx.

Winston Wong, Pharm.D., president of W-Squared Group, says that he expects Orgovyx to have “significant uptake for several reasons. Even though it is taken daily, it is easier for the patient to be treated when compared to the patient having to travel to the physician office to receive their injection.”

He says he expects prescriptions to drop for Lupron and Eligard. “Possibly the remaining niche for either of these injectable drugs would be for the traditional Medicare patient who does not have a prescription plan through Part D or a Medicare Advantage plan.”