June 2024
Volume 1, Issue 6
Inside this issue
Sobi policy announcement
Bausch & Lomb announcement
Vertex announcement
Other manufacturer updates
State bill updates
CE owned retail pharmacies
Alkermes Becomes the 36th Drug Manufacturer to Impact the 340B Contract Pharmacy Program
On June 7th, Alkermes was among several recent updates sent to Covered Entities detailing their new 340B Contract Pharmacy Policy update, which will take effect on July 22nd, 2024.
These changes are similar to other manufacturers, including providing an option for those Covered Entities that do not have their own open-door pharmacy to designate a single contract pharmacy to continue receiving inventory purchased at the 340B ceiling price.
There are exceptions to this policy:
340B entities located in Arkansas may continue shipping 340B priced inventory to multiple pharmacies that have Arkansas addresses.
340B entities located in Louisiana may continue shipping 340B priced inventory to multiple pharmacies that have Louisiana addresses.
340B entities located in West Virginia may continue shipping 340B priced inventory to multiple pharmacies that have West Virginia addresses.
The rest of the 340B Covered Entities will have to follow this policy and are requested to voluntarily submit claims data for all Alkermes’ products purchased until the 340B Program within 45 days after the dispense data via the 340B ESP™ database.
Sobi 340B Contract Pharmacy Policy Update
Effective July 1st, Sobi will ship products purchased at the 340B price exclusively to locations registered as a 340B covered entity or child site locations. For those covered entities that do not have an in-house pharmacy capable of dispensing 340B purchased drugs to its patients may designate a single contract pharmacy within a 40-mile radius of the parent site.
Sobi will be utilizing the 340B ESP™ platform to support the designations. In order for the designated pharmacy not to lose access to the 340B ceiling price, designations will need to be made by June 30th.
Not all of Sobi’s NDCs will be impacted by this; however, this does apply to the following drugs:
Doptelet
Kineret
Vonjo
Bausch & Lomb 340B Contract Pharmacy Policy Update
Effective July 1st, Bausch & Lomb Americas Inc. will exclusively ship products purchased at the 340B price to locations registered as a 340B covered entity or child site location. Those covered entities that do not have an in-house pharmacy capable of dispensing 340B purchased drugs to its patients may designate a single contract pharmacy within a 40-mile radius of the parent site.
Bausch & Lomb will utilize the 340B ESP™ platform to support the designations. The designated pharmacy must make designations by June 30th to avoid losing access to the 340B ceiling price.
Bausch & Lomb welcomes the voluntary submission of the 340B program, which must be submitted within 45 days of the dispense date.
Bausch & Lomb provided an NDC list that covered entities can review to determine which pharmacy would be the best designated pharmacy in the event that the covered entity has multiple contract pharmacy relationships.
Vertex 340B Contract Pharmacy Policy Update
Effective July 1st, Vertex will limit the distribution of 340B-priced products in accordance with its Cystic Fibrosis products.
This policy change includes the following drugs:
KALYDECO® (invacaftor)
ORKAMBI® (lumacaftor/ivacaftor)
SYMDEKO® (tezacaftor/ivacaftor and ivacaftor)
TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor)
Vertex does have some exceptions to this policy:
340B entities located in Arkansas, Kansas, Louisiana, Maryland, Mississippi, and West Virginia may continue shipping 340B priced inventory to multiple pharmacies in their states.
Federal Grantees
Vertex is utilizing the 340B ESP™ platform to facilitate contract designations. In order to ensure that the designated pharmacy doesn’t risk losing pricing, designations will need to be assigned by June 17th.
Other Recent Updates to Contract Pharmacy Policies
Within the last three weeks, many updates have been made with manufacturers’ current 340B contract pharmacy policies. While these updates might not impact everyone, it’s important to know the facts and analyze data to ensure designations are made with the best interest for those patients that this will impact.
Review the following recent updates:
Bayer: Beginning June 24th, Bayer has included Nubega in its current policy.
Bristol Myers Squibb: Effective July 1st, BMS will require claims-level data submission for all non-lMiDs, Camzyos, and lMiDs dispensations. Covered entities are allowed to choose three different pharmacies; one for non-lMiDs, second for Camzyos, and third for lMiDs.
Exelixis: Effective July 1st, Exelixis will begin allowing a hospital covered entity to designate a single contract pharmacy within their specialty pharmacy network if the entity does not have an in-house pharmacy or wholly owned (or common ownership) contract pharmacy. Claims data must be provided for contract pharmacy 340B dispensations. Exception: Federal Grantees are not subject to limitations.
GSK: GSK is now allowing West Virginia covered entities to place 340B replenishment orders to their designated contract pharmacies. For specialty/oncology products, the contract pharmacies must be part of GSK’s limited pharmacy network.
Pfizer: Now allowing West Virginia and Arkansas hospital covered entities to order 340B replenishment to registered contract pharmacies. For Vyndamax and Vyndaquel, these pharmacies may engage in multiple VYNDA Network Specialty contract pharmacy arrangements without providing limited claims data. For oral oncology medicines (DON), they may engage in multiple DON Network specialty contract pharmacy arrangements without providing limited claims data.
Sandoz: Effective July 1st, Sandoz will include Zarxio in its policy.
Sanofi: Effective July 1st, Sanofi is now requiring claims data to be submitted through the 340B ESP™ platform for contract pharmacy designations to continue having access to the 340B ceiling price.
Teva: Now including Simlandi in its 340B contract pharmacy policy.
Current Status on State Bills and Laws that Prohibit Drugmaker 340B Contract Pharmacy Restrictions
*States in Bold are the newest updates since last month
Enhancing Access and Care: The Role of 340B Covered Entities’ Open Door Retail Pharmacies
In healthcare, accessibility and affordability are pivotal pillars for ensuring that individuals receive the treatment and medications they need. One significant avenue through which this objective is pursued is the establishment of 340B Covered Entities' open-door retail pharmacies. These pharmacies, often affiliated with healthcare facilities, serve a dual purpose of expanding access to medications while maximizing the benefits of the 340B Drug Pricing Program. Let's delve into the benefits of these pharmacies and their profound impact on healthcare delivery.
Bridging Gaps in Access
Geographic Accessibility: One of the primary advantages of open-door retail pharmacies operated by 340B Covered Entities is their strategic placement within or near healthcare facilities. This proximity ensures patients have convenient access to prescription medications immediately following their appointments or treatments. These pharmacies become invaluable lifelines for individuals residing in medically underserved areas, eliminating barriers such as transportation challenges that might otherwise hinder medication adherence.
Timely Availability: By integrating pharmacies within healthcare settings, patients can promptly obtain their prescribed medications without the delay often associated with third-party pharmacies. This immediate access fosters patient satisfaction and contributes to better health outcomes by ensuring the timely commencement of treatment regimens.
Continuity of Care: Open-door retail pharmacies facilitate seamless coordination between healthcare providers and pharmacists, exchanging crucial patient information and fostering collaborative decision-making. This interconnectedness enhances patient safety and medication management, particularly for individuals with complex medical needs or multiple treatments.
Maximizing 340B Program Benefits
Revenue Reinvestment: 340B Covered Entities' open-door retail pharmacies are pivotal in optimizing the benefits derived from the 340B Drug Pricing Program. By leveraging discounted drug prices offered through the program, these pharmacies can reinvest the savings into expanding patient care services, enhancing infrastructure, or subsidizing medications for vulnerable populations. Consequently, the financial sustainability of healthcare organizations is bolstered, allowing them to broaden their scope of services and reach more underserved communities.
Cost Savings for Patients: The overarching goal of the 340B program is to reduce the financial burden of prescription medications on eligible patients. Open-door retail pharmacies affiliated with 340B Covered Entities contribute to this objective by offering significantly lower prices, making essential treatments more affordable and accessible to economically disadvantaged individuals.
Community Engagement: Through their presence in the community, 340B Covered Entities' retail pharmacies foster trust and engagement among residents. By actively participating in health outreach programs, providing education on medication adherence, and offering supportive services, these pharmacies serve as integral components of comprehensive healthcare ecosystems, promoting wellness and preventive care initiatives.
Establishing open-door retail pharmacies by 340B Covered Entities emerges as a transformative endeavor in pursuing equitable healthcare delivery. By strategically integrating pharmacies within healthcare settings and harnessing the benefits of the 340B Drug Pricing Program, these entities enhance access to vital medications and drive positive outcomes in patient care, financial sustainability, and community wellbeing. As we continue to navigate the evolving healthcare landscape, the expansion of such initiatives promises to forge a path toward a more inclusive and accessible healthcare system for all.