PHARMACY

Cost issues aside, outlook solid for continued rise of specialty Rx

BY Jim Frederick

Specialty and biotech medicines aimed at treating cancer, multiple sclerosis and rare diseases will dominate much of drug development in 2017 and beyond, one of the nation’s top specialty pharmacy providers concluded.

(To view the full Category Review, click here.)

In 2016, the number of novel new medicines approved by the Food and Drug Administration “declined substantially compared with each of the previous two years,” noted a new report on specialty drug approvals from Diplomat, the nation’s largest independent specialty pharmacy. But roughly half of the 22 newly developed drugs approved in 2016 are considered specialty pharmaceuticals. The FDA also cleared seven new biologically engineered medicines.

Despite the “perception that fewer novel new drug approvals signifies slowed growth in the specialty market, this number does not speak to the impact of the drugs that were approved … in each of the broad disease states covered by specialty pharmacy,” the report noted.

Specialty drug makers continue to train much of their research and development on four broad disease categories — cancer, autoimmune diseases including multiple sclerosis, hepatitis C and rare diseases.

Only two orally dosed oncology products, AbbVie’s Venclexta (venetoclax) and Rubraca (rucaparib) from Clovis Oncology, won FDA approval in 2016. But that relatively paltry approval rate belies the “overall high level of activity in the oncology pipeline,” Diplomat noted.

“While the number of new approvals was low in oncology for 2016, … there were 15 instances of an oncology agent gaining approval for an expanded indication, new dose formulation, new combination or coverage of an expanded age group,” noted the report.

Diplomat predicts that the pace of approvals for new cancer drugs will accelerate this year, with “multiple approvals … forecast in both breast and blood cancers.”

Oncology meds newly approved or up for expected approval in 2017 or early 2018 include two new treatments for acute myeloid leukemia, Midostaurin from Novartis and Enasidenib from Agios Pharmaceuticals and Celgene. Newly approved for the treatment of marginal zone lymphoma is Imbruvica from Abbvie and Janssen Biotech. Also in the approval pipeline are at least two new breast cancer treatments, including Puma Biotechnology’s Neratanib and Ribociclib from Novartis.

“Oncology will remain a prime focus for drug research and development in future years,” said Murray Aitken, SVP and executive director of QuintilesIMS Health. “Cancer treatments represent the largest category of the 225 new medicines expected to be introduced within the next five years,” he said.

On the immunology front, the FDA cleared two new treatments for autoimmune diseases in 2016, Zinbryta (daclizumab) from Biogen and AbbVie, and Eli Lilly’s Taltz (ixekizumab) to treat moderate to severe plaque psoriasis. Genentech’s Ocrelizumab, granted breakthrough therapy status by the FDA for treatment of primary-progressive MS, is coming in 2017. Also projected for this year are products aimed at atopic dermatitis/eczema — topical Eucrisa from Pfizer and Dupilumab from Regeneron Pharmaceuticals.

So-called orphan drugs targeting rare diseases also remain a prime focus for research and development. Of the 29 new drugs and biologics gaining FDA approval in 2016, nine earned orphan designation.

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PHARMACY

Bad ties, thin hair and strong perspective

BY Rob Eder

Twenty years ago this month, I put on what was then my “lucky” tie, this horrible, neon yellow number from Banana Republic — it wore more like a bad Hawaiian shirt than a tie — and I started a new job as senior editor for OTCs and natural health at Drug Store News.

Sure, I have a lot less hair today than I did then, but I also have much better taste in ties.

And I’ve also enjoyed a pretty good perspective on a lot of the transformation that has occurred in retail pharmacy during that time.

This month also marks the sixth anniversary for a special, stand-alone edition of Drug Store News that was specifically created to help educate policy-makers on the important role community pharmacy plays as the face of health care in neighborhoods all across America. (To view this year’s edition, click here.) Timed with the National Association of Chain Drug Stores’ annual RxIMPACT Day on Capitol Hill, this month, our special RxIMPACT report — sponsored by Upsher-Smith — is delivered to all members of the U.S. House of Representatives and the Senate.

Since it’s all still fresh in my mind, here’s a quick, five-point pitch on the value of community pharmacy — just in case you get caught in an elevator with your local congressman:

  • Pharmacists are the most accessible of all healthcare professionals. More than 90% of Americans live within five miles of a community pharmacy;
  • People trust the advice of the pharmacist. Pharmacists consistently rank second only to nurses among the most honest, ethical and trustworthy of all professions, according to an annual Gallup survey;
  • Pharmacy lowers costs. Roughly two-thirds of likely voters said pharmacists provide credible advice that helps them save money;
  • Pharmacy improves quality of care. Pharmacists do a lot more than just fill prescriptions. Pharmacists provide flu shots and other important vaccinations; they provide important disease-state management counseling and ensure patients take their medications as prescribed; and many are working in partnership with local hospitals and health systems to help patients transition successfully from the hospital back into their homes, lowering readmission rates; and
  • Pharmacy brings innovation to health care. The industry continues to work on cutting-edge patient care programs, most recently including a personalized medicine pilot that is using pharmacogenomic testing to match patients to the most effective and cost-efficient therapy. Another focuses on the testing and treatment of flu and strep in a community pharmacy setting.

And lastly, tell them they don’t have to take your word for it. Invite them to visit a pharmacy in their district and see for themselves what pharmacy is doing to be the face of neighborhood health care.

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PHARMACY

Key approvals see big sales in first months

BY David Salazar

Among the 22 novel new drugs approved by the Food and Drug Administration in 2016, about half were considered specialty drugs, and Diplomat identified four key specialty approvals that innovate in certain categories. Two of these were in the hepatitis C space, which has driven specialty growth for several years.

(To view the full Category Review, click here.)

Gilead’s Epclusa (velpatasvir and sofosbuvir), approved in January, currently is the only treatment on the market that offers a singletablet regimen for patients with genotype 1–6 chronic hepatitis C — a U.S. patient population estimated between 2.7 million and 3.9 million. Despite being on the market for less than half the year, Gilead reported that Epclusa brought in U.S. sales of $1.6 billion for the company in 2016.

Also in the hepatitis C space was Merck’s Zepatier (elbasvir and graziprevir), which received breakthrough therapy designation for certain genotype 1 patients and genotype 4 patients. The total patient population for the drug is around 71% of the total hepatitis C patient population, and Merck reported Zepatier sales of $488 million in the United States, with $180 million in fourth-quarter U.S. sales.

The drug with the largest patient population (7.5 million) was Eli Lilly’s Taltz (ixekizumab), a new treatment for certain plaque psoriasis patients. Upon approval in March 2016, the drug joined the therapeutic class of such blockbuster drugs as Cosentyx, Enbrel, Humira and Remicade. In 2016, Taltz drew $110 million in sales.

On the other end of the patient population spectrum was AbbVie’s Venclexta (venetoclax), a treatment for certain patients with chronic lymphocytic leukemia that can treat about 20% of CLL patients — 18,960 cases were diagnosed in 2016. The drug was given accelerated approval based on overall response rate, and though AbbVie has not disclosed sales, Thomson Reuters’ “Drugs To Watch 2016” report projected that it would see $1.5 billion in sales by 2020.

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