Michael Storey

Pharmacy leader specializing in operationalizing complex and life-changing therapies for kids

[Michael Storey @storeyrx]

@marcellstrbich @realDonaldTrump @RobertKennedyJr @matthuffman1 @GovMikeDeWine Because HB 73 has nothing to do with PBMs.

[Michael Storey @storeyrx]

@ASHP_EmergSci Blake and I will be presenting at ASHP Midyear 2024 on this topic - we welcome all to attend Tuesday at 4-5pm.

I will also have a separate presentation Monday from 4:30-5:15pm on Gene Therapy Adverse Effect Management.

Both of these presentations will provide more info!

[Michael Storey @storeyrx]

@ASHP_EmergSci @nephpharm Blake and I will be presenting at ASHP Midyear on this topic - we welcome all to attend Tuesday at 4-5pm in NOLA!

I will also have a separate presentation Monday from 4:30-5:15pm on Gene Therapy Adverse Effect Management.

Both of these presentations will provide more info!

[Michael Storey @storeyrx]

@ASHP_EmergSci Developing USP 800 policies and procedures for compounding will be a key to success. Gene and cell therapies do not fit easily into current standards and guidelines for pharmacy. It is imperative to stay current on the latest news and publications on handling of G&C therapies.

[Michael Storey @storeyrx]

@ASHP_EmergSci While most will not qualify as a hazardous drug per NIOSH, the toxicity could be considered “serotoxicity” or “immunotoxicity.” Health-system workers can mitigate this risk by wearing appropriate personal protective equipment when handling the therapy and patient waste.

[Michael Storey @storeyrx]

@ASHP_EmergSci It is also important to discuss the numerous vials that will be drawn - often without closed system transfer devices.

[Michael Storey @storeyrx]

@ASHP_EmergSci Clinically, centers must have plans for confirming eligibility, providing the infusion, managing adverse effects, and long-term follow-up.

[Michael Storey @storeyrx]

@ASHP_EmergSci Operationally, centers must ensure appropriate cold chain storage, trained personnel, and SOPs are in place.  Financially, centers need to be engaged with confirming benefits, prior authorization, and payor contracting. These all need confirmation prior to ordering gene therapy.

[Michael Storey @storeyrx]

@ASHP_EmergSci It is also important to familiarize yourself with single case agreements and your state Medicaid policies as this is nearly a requirement for each gene or cell therapy to ensure payment.

[Michael Storey @storeyrx]

@ASHP_EmergSci Most importantly, I would include conversations about the cost and benefits to your community for offering these new therapies. While costly, this can be mitigated by advance discussion with senior leaders and finance prior to the therapy approval. Early communication is key!

[Michael Storey @storeyrx]

@ASHP_EmergSci https://t.co/iOf4JjEzbS

[Michael Storey @storeyrx]

@ASHP_EmergSci ASGCT provides a landscape report quarterly to keep up with new publications and FDA approvals. There are many updates coming forth about the handling and safety of viral vector based gene therapies. ASHP continues to provide programming on gene therapy in various formats.

[Michael Storey @storeyrx]

@ASHP_EmergSci Ultimately, I firmly believe that the only viable way for health-systems to expect to be able to sustainably provide these products to patients is to receive revenue for providing them. A specialty pharmacy will not supply the infrastructure or personnel to provide this care.

[Michael Storey @storeyrx]

@ASHP_EmergSci Buy and bill creates revenue to provide resources to manage these therapies - clinically and operationally. White bagging may appeal to an organization that does not have the financial support to offer the therapies but can manage the patients clinically and operationally.

[Michael Storey @storeyrx]

@ASHP_EmergSci They can cost between $500K to $5M dollars depending on many factors. They are available for 340B drug pricing, dependent on site eligibility and the site of care for the therapy. Some cellular gene therapies must be done inpatient, so 340b is not applicable.

[Michael Storey @storeyrx]

@ASHP_EmergSci Today, gene therapies are approved for a variety of diseases - spinal muscular atrophy has now had an approved gene therapy for 5 years this month, and more recent approvals for Duchenne muscular dystrophy and genetic hematologic diseases are now starting to be used.

[Michael Storey @storeyrx]

@ASHP_EmergSci While the the first gene therapies were approved in Europe years earlier (with limited uptake), the first approvals in the United States were in 2017, for tisagenlecleucel for leukemia and lymphoma and voretigene neparvovec for a rare from of retinal dystrophy.

[Michael Storey @storeyrx]

@sanofi Yes. All infants are at risk of RSV. Please make enough nirsevimab for all of them.

[Michael Storey @storeyrx]

@sanofi How do you win when you don’t even make enough of your own drugs? RSV season has not started yet. Meanwhile, you tell us you will not take any more orders for nirsevimab 100mg for the remainder of the season. Angry for my patients.