SELPERCATINIB - Generic Drug Details

What are the generic sources for selpercatinib and what is the scope of patent protection?

Selpercatinib is the generic ingredient in one branded drug marketed by Loxo Oncol Eli Lilly and is included in two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Selpercatinib has one hundred and thirty-five patent family members in forty-one countries.

One supplier is listed for this compound.

Summary for SELPERCATINIB

International Patents:	135
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	28
Patent Applications:	171
What excipients (inactive ingredients) are in SELPERCATINIB?	SELPERCATINIB excipients list
DailyMed Link:	SELPERCATINIB at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SELPERCATINIB

Dosage:

CAPSULE;ORAL

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for SELPERCATINIB

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Massachusetts General Hospital	Phase 2
Loxo Oncology, Inc.	Phase 1
Loxo Oncology, Inc. a wholly owned subsidiary of Eli Lilly and Company	Phase 1

See all SELPERCATINIB clinical trials

Pharmacology for SELPERCATINIB

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors P-Glycoprotein Inhibitors Rearranged during Transfection (RET) Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for SELPERCATINIB

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for SELPERCATINIB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RETEVMO	Capsules	selpercatinib	40 mg and 80 mg	213246	1	2024-05-08

US Patents and Regulatory Information for SELPERCATINIB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	TABLET;ORAL	218160-004	Apr 10, 2024		RX	Yes	Yes
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-001	May 8, 2020		RX	Yes	No
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-002	May 8, 2020		RX	Yes	Yes			Y
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	TABLET;ORAL	218160-004	Apr 10, 2024		RX	Yes	Yes			Y	Y
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	TABLET;ORAL	218160-004	Apr 10, 2024		RX	Yes	Yes
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	CAPSULE;ORAL	213246-001	May 8, 2020		RX	Yes	No
Loxo Oncol Eli Lilly	RETEVMO	selpercatinib	TABLET;ORAL	218160-003	Apr 10, 2024		RX	Yes	No

EU/EMA Drug Approvals for SELPERCATINIB

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eli Lilly Nederland B.V.	Retsevmo	selpercatinib	EMEA/H/C/005375 Retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC)advanced RET fusion-positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitoradvanced RET fusion-positive thyroid cancer who require systematic therapy following prior treatment	Authorised	no	no	no	2021-02-11

International Patents for SELPERCATINIB

Country	Patent Number	Title	Estimated Expiration
Japan	2020536900	結晶形態
New Zealand	752793
Serbia	60536
Peru	20190918	COMPUESTOS DE PIRAZOLO[1,5-A]PIRIDINA SUSTITUIDOS COMO INHIBIDORES DE LA QUINASA RET
Taiwan	I791053
Taiwan	201827428
Canada	3039912

SELPERCATINIB Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Selpercatinib

Introduction

Selpercatinib, marketed as Retevmo by Eli Lilly and Company, is a targeted therapy approved for the treatment of locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion. This article delves into the market dynamics and financial trajectory of selpercatinib, highlighting its cost-effectiveness, budget impact, and clinical efficacy.

Clinical Efficacy and Approval

Selpercatinib received accelerated approval from the FDA in September 2022 for its efficacy in treating RET fusion-positive solid tumors, including those in patients who have progressed on or following prior systemic treatment or have no satisfactory alternative treatment options[4].

Key Clinical Findings

• The drug demonstrated an overall response rate (ORR) of 44% and a duration of response (DOR) of 24.5 months in a multicenter, open-label trial (LIBRETTO-001)[4].
• It showed efficacy in various tumor types, including pancreatic adenocarcinoma, colorectal, salivary, and others.

Cost-Effectiveness Analysis

The cost-effectiveness of selpercatinib has been a subject of extensive analysis, particularly in comparison to other treatments like vandetanib and best supportive care (BSC).

First-Line Treatment

In the first-line setting, selpercatinib was compared to vandetanib for the treatment of RET-mutant medullary thyroid cancer (MTC). The analysis revealed:

• An incremental cost of $372,869 and 1.66 additional quality-adjusted life years (QALYs) over a 10-year horizon, resulting in an incremental cost-effectiveness ratio (ICER) of $224,435 per QALY[1].

Second-Line Treatment

In the second-line setting, selpercatinib was compared to BSC:

• It was associated with an incremental cost of $430,822 and 1.88 additional QALYs over a 10-year horizon, resulting in an ICER of $228,825 per QALY[1].

Limitations and Uncertainties

The cost-effectiveness analysis was marred by several limitations, including uncertain comparative clinical evidence, lack of transparency in the economic model, and methodological issues. These factors suggest that significant price reductions would be necessary for selpercatinib to be considered cost-effective at a willingness-to-pay threshold of $50,000 per QALY[1].

Budget Impact Analysis

The introduction of selpercatinib as a tumor-agnostic treatment has been evaluated for its budget impact on US healthcare payers.

Commercial Perspective

• The analysis estimated that approximately 7.59 to 8.76 patients per million would be treated with selpercatinib annually over a three-year period.
• The associated incremental total costs were estimated to be $873,099 in the first year, increasing to $2,561,281 by the third year. The per-member-per-month (PMPM) costs were modest, ranging from $0.073 to $0.213 over the three years[3].

Medicare Perspective

• For Medicare, the estimates were higher, with 36.29 to 41.87 patients per million treated annually.
• The incremental total costs were $4,447,832 in the first year, increasing to $12,637,458 by the third year. The PMPM costs ranged from $0.371 to $1.053 over the three years[3].

Key Drivers of Costs

• Drug costs, market share of selpercatinib, incidence of RET-altered tumors, and treatment duration were identified as significant drivers of incremental costs in the budget impact analysis[3].

Market Share and Patient Eligibility

The market share of selpercatinib is expected to grow as more patients are identified with RET fusion-positive tumors.

Patient Eligibility

• Approximately 11.68 patients per million with RET-altered tumors are estimated to be treatment-eligible annually in the commercial sector, with higher numbers in the Medicare population[3].

Forecasted Market Share

• The forecasted market share of selpercatinib is expected to increase over the first three years, contributing to the incremental costs but also reflecting the drug's growing acceptance and use[3].

Pricing and Cost Considerations

The pricing of selpercatinib is a critical factor in its market dynamics and financial trajectory.

Current Pricing

• The monthly wholesale acquisition cost (WAC) for selpercatinib is substantial, contributing to the high incremental costs observed in the cost-effectiveness and budget impact analyses[5].

Necessary Price Adjustments

• For selpercatinib to be considered cost-effective, significant price reductions (up to 78% and 87% compared to vandetanib and BSC, respectively) may be necessary at a willingness-to-pay threshold of $50,000 per QALY[1].

Adverse Reactions and Safety Profile

While selpercatinib has shown promising efficacy, its safety profile is also an important consideration.

Common Adverse Reactions

• The most common adverse reactions include edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache[4].

Regulatory and Expedited Programs

Selpercatinib's approval was facilitated through several FDA expedited programs.

Accelerated Approval

• The drug received accelerated approval based on overall response rate and duration of response, with continued approval contingent upon verification of clinical benefit in confirmatory trials[4].

Priority Review and Orphan Drug Designation

• Selpercatinib was granted priority review and orphan drug designation, reflecting its potential to address significant unmet medical needs[4].

Conclusion

Selpercatinib represents a significant advancement in the treatment of RET fusion-positive solid tumors, but its market dynamics and financial trajectory are complex.

• Clinical Efficacy: Selpercatinib has demonstrated strong clinical efficacy, particularly in patients with limited treatment options.
• Cost-Effectiveness: The drug faces challenges in terms of cost-effectiveness, requiring significant price reductions to meet standard thresholds.
• Budget Impact: The introduction of selpercatinib is expected to have a modest impact on payer budgets, with incremental costs driven by drug acquisition and treatment duration.
• Pricing and Market Share: Pricing adjustments and growing market share will be crucial in determining the long-term financial viability of selpercatinib.

Key Takeaways

• Selpercatinib is a clinically effective treatment for RET fusion-positive solid tumors.
• The drug's cost-effectiveness is uncertain and may require significant price reductions.
• Budget impact analyses suggest a modest increase in healthcare costs.
• Regulatory expedited programs facilitated its approval, highlighting its potential to address unmet medical needs.

FAQs

What is selpercatinib used for?

Selpercatinib is used for the treatment of locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion, particularly in patients who have progressed on or following prior systemic treatment or have no satisfactory alternative treatment options[4].

How does selpercatinib compare to other treatments in terms of cost-effectiveness?

Selpercatinib is associated with high incremental costs compared to vandetanib and best supportive care, requiring significant price reductions to be considered cost-effective at standard willingness-to-pay thresholds[1].

What are the common adverse reactions associated with selpercatinib?

Common adverse reactions include edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache[4].

How does the budget impact of selpercatinib vary between commercial and Medicare perspectives?

The budget impact is estimated to be higher for Medicare, with incremental total costs ranging from $4,447,832 to $12,637,458 over three years, compared to $873,099 to $2,561,281 for commercial payers[3].

What regulatory programs facilitated the approval of selpercatinib?

Selpercatinib received accelerated approval, priority review, and orphan drug designation from the FDA, reflecting its potential to address significant unmet medical needs[4].

Sources

1. Pharmacoeconomic Review - Selpercatinib (Retevmo) - NCBI
2. FDA Approves Selpercatinib for RET Fusion–Positive Locally Advanced or Metastatic Solid Tumors - Cancer Network
3. Integrated budget impact model to estimate the impact of introducing tumor-agnostic selpercatinib treatment - PubMed
4. FDA Approves Selpercatinib for Locally Advanced or Metastatic RET Fusion-Positive Solid Tumors - FDA
5. The budget impact of adding pralsetinib to a US health plan - Journal of Managed Care & Specialty Pharmacy