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Pacira (PCRX) Rises on Proposed Exparel Reimbursement Plan

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Pacira BioSciences (PCRX - Free Report) announced that the Centers for Medicare and Medicaid Services (CMS) has proposed the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System rule for 2025. In this rule, Pacira’s lead drug, Exparel (bupivacaine liposome injectable suspension), is among six non-opioid treatments, out of which two are specific to ophthalmology, eligible for separate Medicare reimbursement in both ambulatory surgical centers (ASC) and hospital outpatient (HOPD) settings. This policy is set to take effect on Jan 1, 2025, pending finalization.

The proposed rule is part of the implementation of the Non-Opioids Prevent Addiction in the Nation Act, which requires separate CMS payments for qualifying non-opioid drugs and devices in HOPD and ASC settings. This law was included in the Consolidated Appropriations Act of 2023.

Please note that Exparel is Pacira’s flagship pain-management product, which was launched in 2012. The drug is indicated for single-dose administration into the surgical site to produce postsurgical analgesia in patients aged six years and older. It is also indicated for regional analgesia in adults via an interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa and femoral nerve block in the adductor canal.

To date, Exparel has been used in more than 14 million patients across the United States.

Per Pacira, the inclusion of Exparel as one of only six qualifying non-opioid drugs for treating postsurgical pain in the proposed reimbursement policy reform will increase patient and provider access to non-opioids. Management also believes that this new reimbursement, once finalized, will enable clinicians to provide long-lasting non-opioid pain control with Exparel and facilitate a smoother transition to outpatient care.

The proposed Medicare payment rates for covered non-opioid drug products, as outlined in the rule, will be set at the average sales price plus 6% in both HOPD and ASC settings. Following this equation, the reimbursement rate for Exparel has been set at $1.41 per billing unit.

Shares of Pacira gained 7.2% on Jul 11, in response to the encouraging news. Year to date, the stock has plunged 35.4% compared with the industry’s 6.5% decline.

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Exparel is the majority contributor to Pacira’s revenues. It has been witnessing strong demand, primarily driven bygrowth within existing accounts, along with increasing acceptance by major hospitals and orthopedic centers, as it continues to be used in orthopedic procedures. It is also ticking the interest among oral and maxillofacial surgeons, fueled by a partnership announced in September 2022 between Pacira and Sevaredent to provide expanded access to Exparel for patients undergoing oral and maxillofacial procedures.

In the first quarter of 2024, the drug generated revenues worth $132.4 million, which rose 1.5% from the year-ago quarter.

Pacira is also looking to further expand Exparel’s label to treat younger age groups. During the first quarter of 2024, the company initiated an early-stage pharmacokinetic study of Exparel as a single-dose post-surgical infiltration administration in patients under six years of age.

Subject to the success of this study, Pacira plans to initiate a phase III registration study to support regulatory filings seeking label expansions in the United States and EU. Potential approval will further boost sales by increasing its patient eligibility criteria.

Besides Exparel, Pacira also markets Zilretta, approved as an extended-release intra-articular therapy providing relief to osteoarthritis (OA) patients with knee pain and the iovera drug delivery system, which generates incremental revenues for the company. 

Pacira is also currently looking to expand Zilretta’s indication to include treatment for OA pain of the shoulder. Potential approval will further drive up Zilretta sales which could relieve some of the burden on Exparel sales to generate revenues.

Zacks Rank and Other Stocks to Consider

Pacira currently carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks from the drug/biotech industryare Arcutis Biotherapeutics (ARQT - Free Report) , Annovis Bio (ANVS - Free Report) and Compugen (CGEN - Free Report) . While CGEN currently sports a Zacks Rank #1 (Strong Buy), ANVS and ARQT carry a Zacks Rank #2 each, at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 30 days, the Zacks Consensus Estimate for Compugen’s 2024 earnings per share has remained constant at 5 cents. The consensus estimate for 2025 loss per share is currently pegged at 11 cents. Year to date, shares of CGEN have lost 11.6%.

CGEN’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 5.79%.

In the past 30 days, the Zacks Consensus Estimate for Arcutis Biotherapeutics’ 2024 loss per share has remained constant at $1.60. During the same period, the consensus estimate for 2025 loss per share has remained constant at $1.14. Year to date, shares of ARQT have skyrocketed 232.2%.

Arcutis Biotherapeutics beat estimates in three of the trailing four quarters and missed once, delivering an average earnings surprise of 14.93%.

In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has remained constant at $1.95. Year to date, shares of ANVS have plunged 29.9%.

ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.

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