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Does SGK Cover Perjeta (Pertuzumab)? Litigation for Off-Label Use

Which HER2-positive breast cancer cases SGK covers for Perjeta (pertuzumab), the legal route for off-label use, and the 2026 price.

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Perjeta (pertuzumab) is a targeted therapy used together with trastuzumab (Herceptin) in the treatment of HER2-positive breast cancer. Unlike many other targeted cancer drugs, Perjeta was added to SGK's Reimbursable Drugs List (Annex 4/A) in 2016 and is covered by SGK when used within its approved indication. In practice, disputes arise mainly when the drug is intended for use outside the protocol or indication defined in the Health Implementation Communiqué (SUT) — for example, in a different treatment line or a different combination.

What Is Perjeta (Pertuzumab)?

Pertuzumab is a monoclonal antibody that binds to the HER2 receptor on cancer cells at a different site than trastuzumab. Combined use of the two drugs allows for more comprehensive blockade of the HER2 signalling pathway. Perjeta is mainly used in:

  • Metastatic HER2-positive breast cancer, as first-line combination therapy with trastuzumab and docetaxel in patients who have not previously received anti-HER2 therapy or chemotherapy for metastatic disease
  • Neoadjuvant therapy (pre-surgery): for locally advanced, inflammatory, or early-stage tumours (larger than 2 cm or node-positive)
  • Adjuvant therapy (post-surgery): for patients at high risk of recurrence

When Does SGK Cover Perjeta?

Because Perjeta is listed in SUT's Annex 4/A, it is covered by SGK when used in line with the approved indication and protocol listed above. The conditions generally required are:

  • HER2 positivity confirmed by a pathology report,
  • Combined use with trastuzumab,
  • Prescription matching one of the metastatic, neoadjuvant, or adjuvant treatment settings,
  • A health board report issued by a medical oncologist.

The problem arises when the patient's clinical picture falls entirely outside the protocol described in SUT — for example, when the treating physician determines that the drug is needed in a combination, treatment line, or indication not foreseen by SUT. In that case SGK may classify the request as "off-label use" and reject it, at which point the patient's legal remedy becomes relevant.

Perjeta 2026 Price

Based on current data, a 420 mg vial of Perjeta costs approximately 76,500 TL. Because the loading dose administered at the start of treatment is double the maintenance dose, the cost of the first cycle reaches approximately 153,000 TL, with subsequent cycles billed at the per-vial price. Since Perjeta is typically administered every three weeks, the total cost can rise considerably depending on the length of treatment. When used within the approved indication and SUT conditions, this cost is expected to be covered by SGK; if refused, an action to annul the administrative decision is available.

Legal Process When SGK Refuses Payment

A) Unjustified refusal within the approved indication: If the patient's clinical picture meets the conditions defined in SUT yet SGK refuses payment, an action can be filed directly for annulment of the decision; an interim injunction may also be requested so that treatment is not interrupted.

B) Use outside the approved indication: If the treating physician determines that Perjeta must be used in a manner not defined in SUT, the process proceeds as follows:

  1. Application to TİTCK for off-label use approval, demonstrating that the drug's benefit is supported by scientific literature and that no alternative exists.
  2. Written application to SGK, accompanied by the physician's report, pathology results, and any TİTCK approval.
  3. If SGK refuses or fails to respond, a case is filed before the labour court or the administrative court depending on the patient's insurance status.
  4. A request for an interim injunction so that SGK covers the drug while the case is pending.
  5. Expert examination: if the court-appointed experts confirm the drug is medically necessary, the court may order SGK to pay.

Required Documents

  • Pathology report confirming HER2 positivity
  • Health board report from an oncology specialist (stating treatment line and combination)
  • Discharge summary and prior treatment records
  • TİTCK application/approval documents, if off-label use is involved
  • SGK refusal letter or application record
  • Invoices, if the cost was paid out of pocket

Duration of Proceedings

Cases based on an unjustified refusal within the approved indication tend to proceed relatively predictably because the SUT provisions are clear, whereas cases based on off-label use generally take 6 to 18 months due to the expert examination process.

Frequently Asked Questions

Is Perjeta on the SGK reimbursement list?

Yes, Perjeta has been listed in SUT's Annex 4/A since 2016 and is covered by SGK when used within its approved indication.

Which drug is Perjeta used together with?

It is used in combination with trastuzumab (Herceptin) and, typically, docetaxel.

Why would SGK refuse payment for a listed drug?

Being on the list does not mean every mode of use is automatically covered; if the use does not match the protocol defined in SUT (indication, combination, treatment line), SGK may refuse.

Is Perjeta covered in early-stage breast cancer?

It may be covered under neoadjuvant/adjuvant treatment for patients at high risk of recurrence who meet the clinical criteria; if the criteria are deemed unmet, refusal and litigation may follow.

How can I obtain Perjeta while the case is ongoing?

A court-ordered interim injunction can ensure SGK covers the drug cost until the case is concluded.

Frequently Searched Questions

How Should a Petition for a Perjeta SGK Application Be Prepared?

The petition should include a pathology report confirming HER2 positivity, an oncology health board report stating that Perjeta is used in combination with trastuzumab, a discharge summary showing the treatment line (metastatic, neoadjuvant, or adjuvant), and, if applicable, SGK's refusal letter.

Where Is the Cost of Perjeta Obtained From?

Since Perjeta is listed in SUT's Annex 4/A, it is supplied directly through hospital pharmacies under SGK's protocol when used within its approved indication. Where SGK refuses payment, the drug may need to be purchased out of pocket from a private pharmacy while the case is pending.

Can the Amount Paid for Perjeta Be Reclaimed?

Yes. Perjeta costs paid out of pocket due to an unjustified refusal within the approved indication can be reclaimed through litigation, supported by invoices and SGK's refusal letter; the claim is subject to the 5-year limitation period under Article 97 of Law No. 5510.

Why Does SGK Refuse Perjeta Requests?

The most common ground is prescribing the drug without trastuzumab or outside the metastatic, neoadjuvant, or adjuvant treatment lines defined in SUT. A health board report that does not adequately document HER2 positivity or the treatment line is another frequent ground for refusal.

Which Court Hears a Perjeta Case?

Insured persons under SSK or Bağ-Kur file their case before the labour court, while civil servants and retired civil servants within the scope of Article 4/c of Law No. 5510 file before the administrative court.

Related Court Decisions

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