Since becoming aware of disruptions in CADD-MS3 (MS3) access earlier this year, the Pulmonary Hypertension Association (PHA) has been meeting with stakeholders and advocating on behalf of health care professionals and patients.
To date, PHA has met with ICU Medical (device manufacturer); United Therapeutics Corporation (Remodulin); Liquidia (generic treprostinil); and Accredo Specialty Pharmacy. The information below represents PHA’s current understanding of the MS3 shortage, with guidance for health care professionals from PHA’s Scientific Leadership Council.
The MS3 was manufactured by ICU Medical, formerly Smith’s Medical. Since 2009, the MS3 has been used only to administer subcutaneous treprostinil. No other medications or disease communities use this pump.
ICU Medical no longer makes the MS3 but states it plans to service existing pumps until 2025. However, supply chain disruptions, including supply of the pump’s LCD screen, created an abrupt and unexpected slow-down this summer, affecting ICU Medical’s ability to service pumps for reuse. As a result, specialty pharmacies earlier this year halted new patient starts on the MS3.
A finite number of MS3 pumps remain on the market, available for branded Remodulin and generic treprostinil. The Remunity pump is the only alternative to deliver subcutaneous treprostinil.
Remunity is a proprietary system developed by United Therapeutics and is available only to administer Remodulin. The device is FDA-approved for adults over 22. There is no FDA-approved alternative pump to deliver subcutaneous treprostinil or brand or generic treprostinil to people for whom Remunity is not appropriate.
ICU Medical said it was improving its ability to repair existing MS3 pumps and aims to increase the number in circulation. As a precaution in the meantime, PHA encourages adult PAH providers to join a nationwide effort to preserve remaining MS3 pumps for patients who need them, including pediatric and lower-weight patients.
United Therapeutics has indicated it is working on a lower concentration Remodulin that would allow Remunity to be utilized for lower-weight patient and it also is developing next-generation devices to deliver Remodulin that may be available in the future.
Liquidia has indicated that it is working to increase the availability of MS3 pumps to provide continuity for individuals currently prescribed generic treprostinil. Liquidia is also developing an alternate delivery device that it expects to be available well before ICU Medical ends service of existing MS3 pumps in 2025.
Special considerations for health care providers who treat children with PH
As noted above, MS3 pumps are recommended for subcutaneous delivery of treprostinil to pediatric patients or other individuals for whom Remunity is not appropriate. Clinicians who need to use Remunity for pediatric patients should be aware of these additional considerations:
- Insurance denial. Remunity is FDA-approved for people 22 years and older. It isn’t approved for infants, children or adolescents. Providers should anticipate that insurance companies may deny pediatric use. Providers should be prepared to appeal and have an alternative treatment plan in case of unsuccessful appeal.
- Transition to brand product. Remunity can be used only with Remodulin, so health care providers might need to appeal for patients using generic treprostinil.
- Staff training. United Therapeutics has limited resources to train pediatric PH center staff about Remunity. However, pediatric PH staff can request training from Accredo and CVS Specialty Pharmacy.
- Rate restrictions. For infants and toddlers who need to start Remodulin, Remunity’s rate restrictions create challenges related to safe dosing for initiation and titration. For example, an 8-kg infant would need a starting dose of SQ Remodulin at 1-2 ng/kg/min. However, the lowest starting dose for the Remunity pump is 34 ng/kg/min for that weight. The drug must be diluted to effectively treat infants and children.
PHA is monitoring this evolving situation and advocating on behalf of patients and health care professionals for robust, appropriate access to treprostinil. We will provide updates and recommendations as new information becomes available.
To contact PHA’s Advocacy and Treatment Access Program, call 240-485-0749 or email gro.noitaicossAHP@KenirehtaK.