fda-approval-letter
PHARMACY

Coherus BioSciences gets FDA nod for Neulasta biosimilar

BY Sandra Levy

Coherus BioSciences has received the FDA’s clearance for Udenyca, which is a biosimilar of Amgen’s Neulasta. It is the first pegfilgrastim biosimilar approved by the FDA and the European Commission for patients with cancer receiving myelosuppressive chemotherapy, the company said.

Udenyca is a PEGylated growth colony-stimulating factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

“The list price of Neulasta has nearly tripled since approval in 2002 and now represents a $4 billion annual cost burden in the United States. We believe that competition is essential in controlling burdensome price increases, and Udenyca will play an important role in curbing that spend when launched,” Coherus BioSciences chairman and CEO Denny Lanfear said.“Our in-depth understanding of the market will allow us to deliver significant value to patients, payors and providers in the U.S., including 340 billion hospitals, small clinics and small hospitals.”

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PHARMACY

CVS Health opens first MinuteClinic in San Francisco

BY Sandra Levy

A new MinuteClinic walk-in medical clinic has opened inside the CVS Pharmacy store at 1900 19th Avenue in San Francisco, California, providing the community with convenient access to common health care services.

The clinic is the first MinuteClinic location in the city of San Francisco and will be open seven days a week with no appointment necessary, providing wellness services for patients ages 18 months and older.

“Our new clinic will help increase access to high-quality, affordable health care for people who live and work in San Francisco,” MinuteClinic senior vice president and executive director, Sharon Vitti said.

“We’re excited to bring our unique care model to people in San Francisco and we look forward to being a healthcare resource for residents, when and where they need us.”

MinuteClinic is staffed by nurse practitioners who specialize in family health care and can diagnose, treat and write prescriptions for common illnesses such as strep throat and ear, eye, sinus, bladder and bronchial infections. Minor wounds and abrasions, and sprains, strains and joint pain are treated, and common vaccinations for conditions such as influenza, tetanus, pneumonia and hepatitis A and B are available.

Prevention and wellness services include screening and monitoring for diabetes, high blood pressure and high cholesterol, tuberculosis testing, contraceptive care, motion sickness prevention and smoking cessation. In addition, MinuteClinic nurse practitioners can evaluate and treat such common skin conditions as acne, dermatitis and rosacea.

Patients receive educational material, a prescription (when clinically appropriate) and a visit summary. A copy of the diagnostic record can be sent electronically, or by fax or mail, to a primary care provider with patient permission.

Most major health insurance is accepted at MinuteClinic.The cost for most services is between $89 and $129.

Individuals who visit MinuteClinic and do not have a primary care provider are given a list of physicians in the community who are accepting new patients.

A new digital tool accessible on the MinuteClinic website allows patients to view wait times at all MinuteClinic locations. Patients can also hold a place in line or schedule a future appointment from the convenience of their smartphone, computer or tablet.

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PHARMACY

Diplomat’s Q3 sees slight loss despite adding PBM revenue

BY Sandra Levy

Diplomat Pharmacy posted $1.4 billion in revenue for the third quarter, but the Flint, Mich.-based company’s net income decreased to $0.2 million for the quarter compared with $1 million in the prior-year period.

Revenue increased 22% to $1.4 billion from $1.1 billion, and gross profit grew to $93.4 million from $65.1 million in the prior-year period.

“Third quarter results were solid as we continue to successfully execute on our growth plan. Results were driven by strong specialty segment growth and PBM performance,” Diplomat chairman and CEO Brian Griffin said. “We recently opened our new state-of-the-art distribution and call center facility in Chandler, Ariz., furthering our efforts to provide the highest quality patient care nationwide. Every day we put our patients first, while at the same time investing in initiatives to drive further growth and productivity.”

Revenue was comprised of $1.2 billion from the company’s specialty segment and $170 million from its pharmacy benefit management segment. The PBM segment was not part of the business in the prior-year period.

The company said the increase in the specialty segment was driven by manufacturer price increases, approximately $10 million from its recent acquisitions, access to drugs that were new in the past year, and increased volume due to both payer and physician relationships. These increases were partially offset by a decrease in hepatitis C business versus the prior-year period and reimbursement compression.

Gross profit in the third quarter generated a 6.8% gross margin, compared with 5.8% gross margin in the third quarter of 2017. Gross profit was comprised of $67 million from the specialty segment and $26.3 million from the PBM segment. The gross margin increase in the quarter was primarily due to the impact of PBM acquisitions, partially offset by reimbursement compression in its specialty segment, the company said.

Net income for the quarter was $0.2 million — down from $1.0 million year over year. Diplomat cited an $8.1 million increase in interest expense due to a significant increase in outstanding debt to fund its PBM acquisitions, partially offset by a $7.6 million increase in income from operations.

Adjusted EBITDA for the third quarter was $41.9 million, up from $23.2 million a year ago, and earnings per share were $0 versus 1 cent the prior year period.

Diplomat adjusted its full-year outlook to project revenue of between $5.5 and $5.7 billion, versus the previous range of $5.5 and $5.9 billion. Its expected EBITDA range is between $164 and $170 million, which is consistent with its previous range.

Diplomat now expects diluted earnings per share to be between 10 cents and 3 cents, versus the previous range of 15 cents and 1 cent.

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