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CMS: Medicare Advantage Plans Can Require Step Therapy
¡XInsurers can impose this form of prior authorization for Part B drugs next yea
by Shannon Firth, Washington Correspondent, MedPage Today August 08, 2018
WASHINGTON -- The Centers for Medicare and Medicaid Services (CMS) will allow Medicare Advantage plans in 2019 to apply a step therapy approach to Part B drugs.
CMS made the announcement and issued a memo detailing the changes on Tuesday afternoon.
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There¡¦s just one problem. Step therapy is a form of prior authorization and physicians really, really hate prior authorization, viewing it as disrupting the patient-physician relationship and creating an unnecessary burden.
In step therapy, patients must attempt another similar but typically less expensive medication before they can be prescribed a pricier one.
CMS Administrator Seema Verma told reporters on a conference call that the new approach would ensur[e] that patients receive the most preferred drug therapy first.
The new option for plans would also create a level playing field between Part B and Part D drugs, enabling plans to negotiate better deals for patients, she added.
Part B drugs are typically more expensive and often include biologic agents. They are typically administered by physicians in their office, whereas Part D drugs are those picked up at a pharmacy and self-administered.
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In the past, competition may have been stymied by having a Part B drug under one benefit and its competitor under a separate Part D plan, Verma explained.
Under this new approach CMS would allow plans to cross-manage these medications.
So, if a plan is managing both the Part B benefit and the Part D benefit, they can essentially... require the lower cost drug to be used first, she said.
The agency said Part B drug spending in Medicare Advantage plans totals about $12 billion annually. Another official on the press call said that, in the private sector, step therapy has cut drug spending by 15%-20%.
One group celebrated the planned change.
We applaud the Administration¡¦s focus on bringing down drug prices and increasing access |
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----- ------------------------INDICATIONS AND USAGE---------------------------- SELZENTRY is a CCR5 co-receptor antagonist indicated for combination antiretroviral treatment of adults infected with only CCR5-tropic HIV- 1detectable, who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents (1). Tropism and treatment history should guide the use of SELZENTRY (1).
---------------DOSAGE AND ADMINISTRATION--------------------- When given with strong CYP3A inhibitors (with or without CYP3A inducers) including PIs (except tipranavir/ritonavir), delavirdine (2, 7.1) 150 mg twice daily With NRTIs, tipranavir/ritonavir, nevirapine, and other drugs that are not strong CYP3A inhibitors or CYP3A inducers (2, 7.1) 300 mg twice daily With CYP3A inducers including efavirenz (without a strong CYP3A inhibitor) (2, 7.1) 600 mg twice daily www.accessdata.fda.gov/drugsatfda_docs/label/2007/022128lbl.pdf |
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FDA Accepts Biologics License Application for Filing and Grants Priority Review for Sacituzumab Govitecan for the Treatment of Metastatic Triple-negative Breast Cancer
GlobeNewswire¡EJuly 18, 2018 MORRIS PLAINS, N.J., July 18, 2018 (GLOBE NEWSWIRE) -- Immunomedics, Inc., (IMMU) (¡§Immunomedics¡¨ or the ¡§Company¡¨), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company¡¦s Biologics License Application (BLA) for filing and granted Priority Review for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who previously received at least two prior therapies for metastatic disease. The PDUFA target action date is January 18, 2019. If approved, sacituzumab govitecan would be the first and only ADC approved for the treatment of mTNBC.
¡§We are delighted that the FDA has accepted the sacituzumab govitecan BLA for Priority Review,¡¨ commented Michael Pehl, President and Chief Executive Officer. ¡§We will continue to work closely with the regulatory agency as we strive to bring this potential new treatment to mTNBC patients expeditiously.¡¨
The filing is based on Phase 1/2 data of sacituzumab govitecan in mTNBC.
About Sacituzumab Govitecan Sacituzumab govitecan, Immunomedics¡¦ most advanced product candidate, is a novel, first-in-class antibody-drug conjugate (ADC). It is currently under review by the U.S. Food and Drug Administration for accelerated approval as a treatment of patients with metastatic triple-negative breast cancer who previously received at least two prior therapies for metastatic disease. If approved, sacituzumab govitecan would be the first and only ADC approved for the treatment of metastatic triple-negative breast cancer.
About Immunomedics Immunomedics is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer and other serious diseases. Immunomedics¡¦ corporate objective is to become a fully-integrated biopharmaceutical company and a leader in the field of antibody-drug conjugates. For additional information on the Company, please visit its website at immunomedics.com/. The information on its website does not, however, form a part of this press release.
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FDA Accepts Biologics License Application for Filing and Grants Priority Review for Sacituzumab Govitecan for the Treatment of Metastatic Triple-negative Breast Cancer
GlobeNewswire¡EJuly 18, 2018 MORRIS PLAINS, N.J., July 18, 2018 (GLOBE NEWSWIRE) -- Immunomedics, Inc., (IMMU) (¡§Immunomedics¡¨ or the ¡§Company¡¨), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company¡¦s Biologics License Application (BLA) for filing and granted Priority Review for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who previously received at least two prior therapies for metastatic disease. The PDUFA target action date is January 18, 2019. If approved, sacituzumab govitecan would be the first and only ADC approved for the treatment of mTNBC.
¡§We are delighted that the FDA has accepted the sacituzumab govitecan BLA for Priority Review,¡¨ commented Michael Pehl, President and Chief Executive Officer. ¡§We will continue to work closely with the regulatory agency as we strive to bring this potential new treatment to mTNBC patients expeditiously.¡¨
The filing is based on Phase 1/2 data of sacituzumab govitecan in mTNBC.
About Sacituzumab Govitecan Sacituzumab govitecan, Immunomedics¡¦ most advanced product candidate, is a novel, first-in-class antibody-drug conjugate (ADC). It is currently under review by the U.S. Food and Drug Administration for accelerated approval as a treatment of patients with metastatic triple-negative breast cancer who previously received at least two prior therapies for metastatic disease. If approved, sacituzumab govitecan would be the first and only ADC approved for the treatment of metastatic triple-negative breast cancer.
About Immunomedics Immunomedics is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer and other serious diseases. Immunomedics¡¦ corporate objective is to become a fully-integrated biopharmaceutical company and a leader in the field of antibody-drug conjugates. For additional information on the Company, please visit its website at immunomedics.com/. The information on its website does not, however, form a part of this press release. |
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www.drugs.com/history/dupixent.html Dupixent Approval History FDA approved: Yes (First approved March 28th, 2017) Brand name: Dupixent Generic name: dupilumab Dosage form: Injection Company: Sanofi and Regeneron Pharmaceuticals, Inc. Treatment for: Atopic Dermatitis
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SINGAPORE, Aug. 06, 2018 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (NASDAQ:ASLN, TPEx:6497), a clinical-stage biopharmaceutical company targeting cancers that are both highly prevalent in Asia and orphan indications in the United States and Europe, today reported financial results for the quarter ended 30 June 2018 and provided an update on its clinical activities.
Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals, said: ¡§Our successful financing and listing on NASDAQ during the second quarter places us in a strong financial position to accelerate the development of our pipeline of candidates that address unmet medical needs. We are preparing to initiate a phase 1 trial for ASLAN004 for the treatment of atopic dermatitis. The focus is on achieving our milestones, and we look forward to sharing new data from our global late-stage clinical trials for varlitinib later this year.¡¨
Second quarter 2018 and recent business highlights
Completed successful IPO in the US that raised gross proceeds of US$42.2 million and began trading on NASDAQ in May 2018 Presented study design of ongoing global pivotal clinical trial of varlitinib, the TREatmEnT OPPortunity (TREETOPP) study, at the 2018 American Society of Clinical Oncology Meeting in June. Study on track to report topline data in 2019 Presented new phase 1b data on varlitinib in combination with paclitaxel in advanced solid tumours at the 2018 American Society of Clinical Oncology Meeting Filed Clinical Trial Authorisation with Singapore¡¦s Health Sciences Authority to initiate first-in-man studies for ASLAN004 Anticipated upcoming milestones
Topline China pivotal trial data on varlitinib as second line treatment for biliary tract cancer in late 2018 Topline global phase 2 data on varlitinib in gastric cancer in second half of 2018 Interim phase 1/2 data on varlitinib as first line treatment for biliary tract cancer in late 2018 Interim phase 2 data on ASLAN003 in acute myeloid leukaemia (AML) in second half of 2018 Topline global pivotal trial (TREETOPP) data on varlitinib as second line treatment for biliary tract cancer in 2019 Second quarter 2018 financial highlights
Cash used in operations for the quarter ended 30 June 2018 was US$10.0 million compared to US$9.0 million in the same period in 2017 Research and development expense was US$8.3 million and general and administrative expense was US$3.1 million for the second quarter of 2018, compared to US$7.0 million and US$1.9 million respectively in the same period in 2017 Staggered upfront payments of US$12 million in the first quarter and US$11 million in the second quarter of 2018 to Array BioPharma for full exclusive global rights of varlitinib were recorded as intangible assets Net loss for the second quarter of 2018 was US$11.0 million compared to a net loss of US$9.2 million for the second quarter of 2017 Cash, cash equivalents and short-term investments totaled US$45.0 million as of 30 June 2018, which includes proceeds from the US public offering completed in May 2018, compared to US$69.7 million as of 30 June 2017 ASLAN Pharmaceuticals Limited Consolidated balance sheet1 (US dollars, unaudited) |
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